(243 days)
Not Found
No
The device description focuses on electro-mechanical components and vacuum assistance for tissue sampling. There is no mention of AI, ML, or any computational analysis of images or data for diagnostic or operational purposes. The performance studies are bench tests on surrogate tissues, not evaluations of algorithmic performance.
No
The "Intended Use / Indications for Use" section explicitly states "They are to be used for diagnostic purposes only and are not intended for therapeutic uses."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses."
No
The device descriptions clearly detail physical components such as handles, cannulas, motors, vacuum pumps, and batteries, indicating it is a hardware device with electro-mechanical functions, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. They perform tests on samples like blood, urine, tissue, etc., to provide diagnostic information.
- This device is used to obtain the specimen. The SpeedBird devices are biopsy devices designed to collect soft tissue samples from the patient's body. The diagnostic examination happens after the sample is collected, using other methods (like histology).
The intended use clearly states the devices are for "diagnostic sampling of soft tissue" and to "provide soft tissue samples for diagnostic sampling." This indicates their role is in the collection of the sample, not the analysis of it.
N/A
Intended Use / Indications for Use
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissue for histologic examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
SpeedBird Model SB38 Soft Tissue Biopsy Device Description
The SpeedBird Model SB38 Soft Tissue Biopsy Device is a sterile, single-use, percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality.
The handle of the device contains an on/off safety switch, 3-position actuation slide switches that are accessible from either side, a built-in red diode class II or Illa laser pointer light, a removable specimen collection tube, a drive mechanism for advancing and rotating the coring cannula, a built-in vacuum pump and tubing to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable collection receptacle, a DC motor, power indicator light, and a choice of two or three internal 3V batteries.
The working end of the device includes an 88 mm or 109 mm long, 10- to 14-gauge stainless steel one-piece coring cannula including twin opposed cutter blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber.
SpeedBird Model SBU Soft Tissue Biopsy Device Description
The SpeedBird Model SBU Soft Tissue Biopsy Device is a sterile, single-use percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality.
The handle of the device contains an on/off safety switch; a 3-position actuation trigger that is accessible from either side and that is used to activate the motor and to cycle the twin cutter blades between coring and severing modes; and a choice of a built-in vacuum pump and tubing, or tubing only for use with external vacuum. In either choice, vacuum is utilized to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable fluid collection receptacle. Also included is a DC motor, power indicator light, current rectifier, resistors, accessory attachment rail and a receptacle for input of direct or alternating electrical current.
The working end of the device includes an 88 mm or 109 mm long, 10- to 14-gauge stainless steel one-piece coring cannula including twin opposed cutter blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber.
SpeedBird Model SBU99 Soft Tissue Biopsy Device Description
The SpeedBird Model SBU99 Soft Tissue Biopsy Device is a two-component biopsy device comprising a sterile, single-use percutaneous biopsy needle cassette for use within a reusable biopsy needle handle (driver).
-
- The Biopsy Needle Cassette is supplied sterile and is for single-patient use only. This Biopsy Needle Cassette contains all patient contact pathways and is fully disposable. Cleaning, re-processing and/or resterilization of the Biopsy Needle Cassette is prohibited. The Biopsy Needle Cassette drops into the Biopsy Needle Handle (driver) and consists of the following pre-assembled, sterile components:
- A biopsy needle consisting of a stainless steel, one-piece coring cannula with twin opposed cutter blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber;
- A detachable, radiolucent, surgical-grade plastic or stainless steel, coaxial outer tube that surrounds the stainless steel coring cannula and may be used to maintain access to the biopsy site for post-procedure marker placement or for intra-operative imaging; and
- All fluid transport tubing.
-
- The Biopsy Needle Handle (driver) is supplied non-sterile and is reusable. The handle contains an on/off safety switch; a 3-position actuation trigger that is accessible from either side and that is used to activate the motor and to cycle the twin cutter blades between coring and severing modes; and a choice of a built-in vacuum pump and tubing, or tubing only for use with external vacuum. In either choice, vacuum is utilized to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable fluid collection receptacle. Also included is a DC motor, power indicator light, current rectifier, resistors, accessory attachment rail and a receptacle for input of direct or alternating electrical current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, Stereotactic, radiographic (e.g., mammographic)
Anatomical Site
soft tissue, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing:
-
Study endpoints included:
- Evaluate the effectiveness of tissue penetration, tissue sample part-off, and tissue transport, using surrogate models representing a wide variety of tissue densities as would be encountered in clinical biopsy procedures.
- Measure the force of tissue penetration.
- Evaluate sample acquisition for adequacy of providing tissue samples for histopathological evaluation.
- Evaluate effectiveness of the tissue transport mechanisms, including vacuum, fluid flush, and the transport pathway itself, for successful collection of tissue sample cores into the specimen collection tube.
- Evaluate the condition of the needle tip after each tissue sampling pass.
- Evaluate the proper functioning of the driving motor size, gear power train components, driving motor controls, and power source for motor during all penetration passes through surrogate tissues.
-
Test Results:
- In both single insertion, single sample mode (to reflect use of the SpeedBird devices in comparison to the single insertion, single sample BIP® VacuFlash Biopsy System predicate device and the Sanarus Cassi™ II Rotational Core Biopsy System predicate device) as well as the single insertion, multiple sample mode, replicating the method of use of the Magic™ Breast Biopsy Device and Mammotome elite® Biopsy System, the SpeedBird devices effectively penetrated, cored, and severed all surrogate tissue types. All coring passes obtained consistent, predictable, undistorted (by unmagnified visual inspection) composite samples that varied in length and corresponding volume based on operator manually controlled coring excursion lengths, producing full-diameter specimens (uniform diameter over the length of the specimens) which ranged in length from 19mm to 46mm, with corresponding volume measurements.
- Forces required to penetrate surrogate tissues remained low, with no significant change observed over each pass in all tissue types or as depth of penetration increased. SpeedBird devices performed substantially equivalently to the predicate devices for force of penetration in all tissue types. The SpeedBird devices' powered tip rotation utilized for challenging tissue types resulted in substantial improvement (lowering) of forces required to penetrate to a target compared to the predicate devices.
- No tissue sampling bias was noted with either SB38 or SBU.
- SpeedBird needle tips continued to rotate throughout all powered passes in all tissue types and remained undistorted following all portions of the testing.
- Motor torque and battery power remained adequate throughout the procedures, with no requirement to exchange batteries. No significant change in needle rotation speed observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K053151, K051581, K024089, K153709
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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June 19, 2018
TransMed7, LLC James Vetter Chairman 117 Solana Road Portola Valley, California 94028
Re: K173316
Trade/Device Name: SpeedBird Model SB38 Soft Tissue Biopsy Device: SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: May 23, 2018 Received: May 25, 2018
Dear James Vetter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173316
Device Name
SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices
Indications for Use (Describe)
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissue for histologic examination, with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SpeedBird Model SB38, SBU, and SBU99 Soft Tissue Biopsy Devices
510(k) Summary (K173316)
The following information is provided as required by 21 CFR § 807.92 for the SpeedBird Family of Soft Tissue Biopsy Devices 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, a summary is provided of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Submitter Name | TransMed7, LLC |
|---|---|
| Address | 117 Solana Road |
| Portola Valley, CA 94028 | |
| Contact Person | James W. Vetter, MD |
| Chairman, TransMed7, LLC | |
| Telephone: 650-400-0101 Fax: 650-854-5910 | |
| jvetter@transmed7.com | |
| Date of Preparation | October 16, 2017 |
| Trade Names | SpeedBird Model SB38 Soft Tissue Biopsy Device, SpeedBird Model SBU |
| Soft Tissue Biopsy Device, and SpeedBird Model SBU99 Soft Tissue | |
| Biopsy Device | |
| Classification Name | Biopsy Instrument |
| Regulation, Product Code | 21 CFR § 876.1075, Product Code KNW |
| Classification | Class II |
| Predicate Devices | Magic™ Breast Biopsy Device K053151 |
| Sanarus Cassi™ II Rotational Core Biopsy System K051581 | |
| BIP VacuFlash® Biopsy System K024089 | |
| BIP USA Inc. / C.R. Bard Medical, Inc. | |
| Mammotome elite® Biopsy System / Devicor Medical, Inc. K153709 |
Device Descriptions
SpeedBird Model SB38 Soft Tissue Biopsy Device Description
The SpeedBird Model SB38 Soft Tissue Biopsy Device is a sterile, single-use, percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality.
The handle of the device contains an on/off safety switch, 3-position actuation slide switches that are accessible from either side, a built-in red diode class II or Illa laser pointer light, a removable specimen collection tube, a drive mechanism for advancing and rotating the coring cannula, a built-in vacuum pump and tubing to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable collection receptacle, a DC motor, power indicator light, and a choice of two or three internal 3V batteries.
The working end of the device includes an 88 mm or 109 mm long, 10- to 14-gauge stainless steel one-piece coring cannula including twin opposed cutter blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber.
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Image /page/4/Picture/0 description: The image shows the logo for TransMed7, LLC. The text "TransMed7, LLC" is in a bold, dark red font. To the right of the text is a stylized image of a hummingbird, also in dark red. The hummingbird is depicted in flight, with its wings spread.
SpeedBird Model SBU Soft Tissue Biopsy Device Description
The SpeedBird Model SBU Soft Tissue Biopsy Device is a sterile, single-use percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality.
The handle of the device contains an on/off safety switch; a 3-position actuation trigger that is accessible from either side and that is used to activate the motor and to cycle the twin cutter blades between coring and severing modes; and a choice of a built-in vacuum pump and tubing, or tubing only for use with external vacuum. In either choice, vacuum is utilized to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable fluid collection receptacle. Also included is a DC motor, power indicator light, current rectifier, resistors, accessory attachment rail and a receptacle for input of direct or alternating electrical current.
The working end of the device includes an 88 mm or 109 mm long, 10- to 14-gauge stainless steel one-piece coring cannula including twin opposed cutter blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber.
SpeedBird Model SBU99 Soft Tissue Biopsy Device Description
The SpeedBird Model SBU99 Soft Tissue Biopsy Device is a two-component biopsy device comprising a sterile, single-use percutaneous biopsy needle cassette for use within a reusable biopsy needle handle (driver).
-
- The Biopsy Needle Cassette is supplied sterile and is for single-patient use only. This Biopsy Needle Cassette contains all patient contact pathways and is fully disposable. Cleaning, re-processing and/or resterilization of the Biopsy Needle Cassette is prohibited. The Biopsy Needle Cassette drops into the Biopsy Needle Handle (driver) and consists of the following pre-assembled, sterile components:
- A biopsy needle consisting of a stainless steel, one-piece coring cannula with twin opposed cutter a. blades that both core and sever tissue samples for vacuum transport to a detachable collection chamber;
- ﻓ A detachable, radiolucent, surgical-grade plastic or stainless steel, coaxial outer tube that surrounds the stainless steel coring cannula and may be used to maintain access to the biopsy site for postprocedure marker placement or for intra-operative imaging; and
- All fluid transport tubing. ﻥ
-
- The Biopsy Needle Handle (driver) is supplied non-sterile and is reusable. The handle contains an on/off safety switch; a 3-position actuation trigger that is accessible from either side and that is used to activate the motor and to cycle the twin cutter blades between coring and severing modes; and a choice of a builtin vacuum pump and tubing, or tubing only for use with external vacuum. In either choice, vacuum is utilized to augment transporting the specimen collection tube as well as transporting any fluid aspirate to a detachable fluid collection receptacle. Also included is a DC motor, power indicator light, current rectifier, resistors, accessory attachment rail and a receptacle for input of direct or alternating electrical current.
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Image /page/5/Picture/0 description: The image shows the logo for TransMed7, LLC. The text "TransMed7, LLC" is written in a bold, maroon font. To the right of the text is a stylized image of a hummingbird, also in maroon.
Indications For Use
The Indications For Use statements for the SpeedBird Model SB38, Model SBU99 Soft Tissue Biopsy Devices and for the identified predicate devices are listed here, followed by a discussion of the similarities and differences between the Indications For Use.
| Device | Indications For Use Statement |
|---|---|
| SpeedBird Model | |
| SB38, Model SBU, | |
| and Model SBU99 | |
| Soft Tissue Biopsy | |
| Devices | The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices |
| are intended for diagnostic sampling of soft tissue during soft tissue biopsy | |
| procedures. They are to be used for diagnostic purposes only and are not intended | |
| for therapeutic uses. | |
| The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices | |
| are indicated to provide soft tissue samples for diagnostic sampling of soft tissue | |
| abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and | |
| various other soft tissue abnormalities. They are designed to provide soft tissue for | |
| histologic examination, with partial or complete removal of the imaged abnormality. | |
| The extent of histologic abnormality cannot be reliably determined from imaging | |
| appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue | |
| abnormality. Therefore, the extent of removal of the imaged evidence of an | |
| abnormality does not predict the extent of removal of a histologic abnormality (e.g., | |
| malignancy). When the sampled abnormality is not histologically benign, it is | |
| essential that the tissue margins be examined for completeness of removal using | |
| standard surgical procedures. | |
| Magic™ Breast | |
| Biopsy Device | |
| K053151 | The Rubicor Magic ™ Breast Biopsy Device is intended for diagnostic sampling of |
| breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes | |
| only and is not intended for therapeutic uses. | |
| The Rubicor Magic ™ Breast Biopsy Device is indicated to provide breast tissue | |
| samples for diagnostic sampling of breast abnormalities. It is designed to provide | |
| breast tissue for histologic examination with partial or complete removal of the | |
| imaged abnormality. | |
| The extent of histologic abnormality cannot be reliably determined from its | |
| mammographic appearance. Therefore, the extent of removal of the imaged | |
| evidence of an abnormality does not predict the extent of removal of a histologic | |
| abnormality (e.g., malignancy). When the sampled abnormality is not histologically | |
| benign, it is essential that the tissue margins be examined for completeness of | |
| removal using standard surgical procedures. | |
| Device | Indications For Use Statement |
| Sanarus Cassi™ II | |
| Rotational Core | |
| Biopsy System | |
| K051581 | The device is indicated for use in obtaining biopsies from soft tissues such as liver, |
| kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. It is not | |
| intended for use in bone. | |
| The device is also indicated to provide breast tissue samples for diagnostic sampling | |
| of breast abnormalities. It is designed to provide breast tissue for histologic | |
| examination with partial or complete removal of the imaged abnormality. | |
| The extent of histologic abnormality cannot be reliably determined from its | |
| mammographic appearance. Therefore, the extent of removal of the imaged | |
| evidence of an abnormality does not predict the extent of removal of a histologic | |
| abnormality (e.g., malignancy). When the sampled abnormality is not histologically | |
| benign, it is essential that the tissue margins be examined for completeness of | |
| removal using standard surgical procedures. | |
| BIP VacuFlash® | |
| Biopsy System | |
| K024089 | The BIP VacuFlash® Biopsy System is indicated to provide breast tissue samples for |
| diagnostic sampling of breast abnormalities. The instrument is designed to provide | |
| breast tissue for histologic examination with partial or complete removal of the | |
| imaged abnormality. | |
| The extent of histologic abnormality cannot be reliably determined from its | |
| mammographic appearance. Therefore, the extent of removal of the imaged | |
| evidence of an abnormality does not predict the extent of removal of a histologic | |
| abnormality (e.g., malignancy). When the sampled abnormality is not histologically | |
| benign, it is essential that the tissue margins be examined for completeness of | |
| removal using standard surgical procedures. | |
| Mammotome elite® | |
| Biopsy System | |
| K153709 | The Mammotome elite® Biopsy System is indicated to obtain tissue samples from the |
| breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The | |
| Mammotome elite® Biopsy System is intended to provide breast tissue for histologic | |
| examination with partial or complete removal of the imaged abnormality. The | |
| Mammotome elite® Biopsy System is intended to provide breast tissue for histologic | |
| examination with partial removal of a palpable abnormality. The extent of a histologic | |
| abnormality cannot always be readily determined from the palpation or imaged | |
| appearance. Therefore, the extent of removal of the palpated or imaged evidence of | |
| an abnormality does not predict the extent of removal of a histologic abnormality, | |
| e.g., malignancy. When the sample abnormality is not histologically benign, it is | |
| essential that the tissue margins be examined for completeness of removal using | |
| standard surgical procedures. In instances when a patient presents with a palpable | |
| abnormality that has been classified as benign through clinical and/or radiological | |
| criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System | |
| may also be used to partially remove such palpable lesions. Whenever breast tissue is | |
| removed, histological evaluation of the tissue is the standard of care. When the | |
| sampled abnormality is not histologically benign, it is essential that the tissue margins | |
| be examined for completeness of removal using standard surgical procedures. |
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Image /page/6/Picture/1 description: The image shows the logo for TransMed7, LLC. The text "TransMed7, LLC" is written in a bold, red font. To the right of the text is a stylized image of a hummingbird, also in red.
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Image /page/7/Picture/0 description: The image shows the logo for TransMed7, LLC. The text "TransMed7, LLC" is in a bold, dark red font. To the right of the text is a stylized image of a hummingbird, also in dark red. The hummingbird is depicted in flight, with its wings spread.
Indications for Use Comparison Discussion
The indications for use for the SpeedBird Soft Tissue Biopsy Devices are essentially the same as the identified predicate device Sanarus Cassi™ II Rotational Core Biopsy System.
The indications for use for the remaining identified predicate devices are a subset (breast tissue target organ indication only) of the SpeedBird Model SB38, Model SBU99 Soft Tissue Biopsy Devices and the Sanarus Cassi™ II Rotational Core Biopsy System.
The wording present in the Sanarus Cassi™ II Rotational Core Biopsy System, the Magic™ Breast Biopsy Device, and the BIP VacuFlash® Biopsy System Indications For Use Statements which states that....
"The extent of histologic abnormality cannot be reliably determined from its mammographic appearance."
...has been modified in the SpeedBird Model SB38, Model SBU99 Soft Tissue Biopsy Devices' Indications For Use Statement to state the following:
"The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality."
Inclusion of this added wording more accurately represents the range of diagnostic imaging and/or functional diagnostic imaging procedures that are currently used for soft tissue imaging and image-guided biopsy procedures, including breast abnormalities. This modification does not affect the safety or effectiveness of the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices when used as indicated.
Technology Comparisons to Predicate Devices
Like all of the identified predicate devices listed in this 510(k) submission, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are handheld, vacuum assisted soft tissue biopsy systems designed for compatibility with imaging guidance.
As with all of the identified predicate devices, the SpeedBird Model SBU, and Model SBU99 Soft Tissue Biopsy Devices utilize a rotating, forward advancing coring cannula to core and sever tissue core samples for histologic analysis, which has been shown to provide more definitive information than cytological analysis alone.
Like the predicate Magic™ Breast Biopsy Device and Mammotome elite® Biopsy System devices, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are capable of single insertion-multiple sampling for procedure efficiency and accuracy as well as to minimize tissue trauma.
Similar to the Mammotome elite® Biopsy System and BIP® VacuFlash Biopsy System predicate devices, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices combine rotational coring and severing with vacuum to enhance tissue extraction from the biopsy site.
As with the Magic™ Breast Biopsy Device and the Sanarus Cassi™ II Rotational Core Biopsy System predicate device, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices utilize open forward-end coring to reduce sampling error to improve imaging-histologic concordance.
As with the Sanarus Cassi™ II Rotational Core Biopsy System predicate device, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated for the same soft tissue biopsy indications and procedures.
Like the Magic™ Breast Biopsy Device predicate device, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices have a detachable tissue receive cored tissue samples.
510(k) Summary of Premarket Notification for the SpeedBird Soft Tissue Biopsy Devices (K173316), Revised 14 June 2018
[Original Date: 16 OCT 2017]
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Additionally, the SpeedBird devices' tissue receptacle is a specimen collection tube that automatically keeps the received samples in sequential order to further improve imaging-histological correlation and enhance concordance between the two.
Like the Mammotome elite® Biopsy System predicate device, the SpeedBird Model SBU, and Model SBU99 Soft Tissue Biopsy Devices incorporate fluid and tissue management using vacuum to augment transport of core samples as well as any fluid aspirate from the biopsy site.
Additionally, like the Mammotome elite® Biopsy System predicate device, the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices use vacuum to augment target tissue acquisition and stability and are thus compatible with non-real time guidance modalities such as stereotactic guidance procedures
The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices incorporate one-piece, combined coring and severing components. This design feature eliminates the need for a separate sharp penetration element, which enhancement also may further reduce potential trauma during placement of the cannula tip prior to initiating the tissue acquisition sequence. Like the BIP® VacuFlash Biopsy System and the Mammotome elite® Biopsy System, the SpeedBird Model SB38, Model SBU99 Soft Tissue Biopsy Devices include a detachable, radiolucent, surgical-grade plastic or stainless steel, coaxial outer tube surrounding the coring cannula which may be used to maintain access to the biopsy site for post-procedure marker placement or for intra-operative imaging.
Like the BIP® VacuFlash Biopsy System and the Sanarus Cassi™ II Rotational Core Biopsy System, the SpeedBird SBU99 Soft Tissue Biopsy Device consists of a sterile biopsy needle (probe) that is to be attached to a non-sterile, reusable biopsy handle (driver).
A direct comparison of the technical and performance characteristics of the SpeedBird Model SBU, and Model SBU99 Soft Tissue Biopsy Devices to the identified predicate devices is provided below:
| Characteristics | SpeedBird
Model SB38 | SpeedBird
Model SBU
and SpeedBird
Model SBU99 | Magic™
Breast
Biopsy
Device | Sanarus
Cassi™ II
Rotational
Core Biopsy
System | BIP®
VacuFlash
Biopsy
System | Mammotome
elite® Biopsy
System |
|-----------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Guidance | Ultrasound & | Ultrasound | Ultrasound | Ultrasound | Ultrasound & | Ultrasound & |
| method | Stereotactic | | | | Stereotactic | Stereotactic |
| Cannula shaft | 10 Gauge – 14 | 10 Gauge — 14 | 10 Gauge | 10 Gauge | 10 and 14 | 10 Gauge & |
| diameter | Gauge | Gauge | | | Gauge | 13 Gauge |
| | Rotating, | Rotating, | Rotating, | Rotating, | Vacuum- | Vacuum- |
| | forward- | forward- | forward- | forward- | assisted side | assisted side |
| | advancing | advancing | advancing | advancing | trough and | trough and |
| Method of | cutting blades | cutting blades | round | round cutter | rotating, | rotating, |
| tissue dissection | with | with | cutter with | with | forward- | forward- |
| | integrated | integrated | specimen | freezing | advancing | advancing |
| | severing | severing | severing | needle | round cutter | round cutter |
| | capability | capability | element | | | |
| Characteristics | SpeedBird
Model SB38 | SpeedBird
Model SBU
and SpeedBird
Model SBU99 | Magic™
Breast
Biopsy
Device | Sanarus
Cassi™ II
Rotational
Core Biopsy
System | BIP®
VacuFlash
Biopsy
System | Mammotome
elite® Biopsy
System |
| Method of
tissue collection | Vacuum,
through to
specimen
collection
tube | Vacuum,
through to
specimen
collection tube | Retention
finger,
transport
tube,
ejection
pin | Freezing
needle
surrounded
by outer
rotating
cutter | Side trough
surrounded
by outer
round cutter | Vacuum,
transport
tube, ejection
pin |
| Patient
contacting
materials | Stainless
steel;
surgical-grade
plastic | Stainless steel;
surgical-grade
plastic | Stainless
steel | Stainless
steel | Stainless
steel;
surgical-
grade plastic | Stainless steel |
| Power source | DC Motor;
Internal built-
in battery
power (3V
batteries) | DC Motor;
Connections
for an external
battery pack
or a
transformer
power source
as desired | DC Motor,
9V battery | DC motor,
compressed
gas, 9v
battery | DC Motor,
rechargeable
battery | DC Motor,
110V AC |
| Hand-held
procedure ? | Yes | Yes | Yes | Yes | Yes | Yes |
| Single use
disposable
device vs.
reusable device | Single use,
fully
disposable | Model SBU:
Single use,
fully
disposable
Model SBU99:
Single use,
disposable
biopsy needle;
reusable
handle (driver) | Single use,
fully
disposable | Single use,
disposable
biopsy
needle
(probe);
reusable
handle
(driver) | Single use,
disposable
biopsy
needle
(probe);
reusable
handle
(driver) | Single use,
disposable
biopsy needle
(probe);
reusable
handle
(driver) |
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The minor differences between the identified predicate devices and the SpeedBird Model SBU, and Model SBU99 Soft Tissue Biopsy Devices' design features and operational principles, namely the shape of the distal-most forward cutting tip which consists of opposing oval blades rather than a single round blade, do not raise any new questions of safety or effectiveness.
Performance Bench Testing
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The performance testing protocol was designed to reflect the similar way in which the relevant predicate devices are used clinically and the SpeedBird Model SB38 and Model SBU devices will be used in clinical procedures, specifically referring to utilizing the single insertion, multiple sampling capability. The predicate devices Magic™ Breast Biopsy Device and Mammotome elite® Biopsy System are both capable of single insertion, multiple sampling; the same as is true of the SpeedBird Model SB38 and SBU devices. Therefore, the bench testing protocol included testing the subject devices in accordance in the instructions for use, namely, utilizing the single insertion, multi-sampling capability of the SpeedBird Model SB38 and the Model SBU devices. The SpeedBird devices were also tested in accordance with single insertion, single sample mode to replicate the BIP® VacuFlash Biopsy System predicate device and the Sanarus Cassi™ II Rotational Core Biopsy System predicate device.
The following summary of performance tests and results with bench testing were provided in support of the substantial equivalence determination.
Final-design prototypes of the SpeedBird Model SB38 and Model SBU devices were operated according to their instructions for use for penetration, coring, part-off, and tissue transport of surrogate tissues. Comparison testing was conducted where applicable.
Study endpoints included the following:
- . Evaluate the effectiveness of tissue penetration, tissue sample part-off, and tissue transport, using surrogate models representing a wide variety of tissue densities as would be encountered in clinical biopsy procedures.
- . Measure the force of tissue penetration.
- . Evaluate sample acquisition for adequacy of providing tissue samples for histopathological evaluation.
- . Evaluate effectiveness of the tissue transport mechanisms, including vacuum, fluid flush, and the transport pathway itself, for successful collection of tissue sample cores into the specimen collection tube.
- . Evaluate the condition of the needle tip after each tissue sampling pass.
- o Evaluate the proper functioning of the driving motor size, gear power train components, driving motor controls, and power source for motor during all penetration passes through surrogate tissues.
Test Results
- . In both single insertion, single sample mode (to reflect use of the SpeedBird devices in comparison to the single insertion, single sample BIP® VacuFlash Biopsy System predicate device and the Sanarus Cassi™ II Rotational Core Biopsy System predicate device) as well as the single insertion, multiple sample mode, replicating the method of use of the Magic™ Breast Biopsy Device and Mammotome elite® Biopsy System, the SpeedBird devices effectively penetrated, cored, and severed all surrogate tissue types. All coring passes obtained consistent, predictable, undistorted (by unmagnified visual inspection) composite samples that varied in length and corresponding volume based on operator manually controlled coring excursion lengths, producing full-diameter specimens (uniform diameter over the length of the specimens) which ranged in length from 19mm to 46mm, with corresponding volume measurements.
- . Forces required to penetrate surrogate tissues remained low, with no significant change observed over each pass in all tissue types or as depth of penetration increased. SpeedBird devices performed substantially equivalently to the predicate devices for force of penetration in all tissue types. The SpeedBird devices' powered tip rotation utilized for challenging tissue types resulted in substantial improvement (lowering) of forces required to penetrate to a target compared to the predicate devices.
- . No tissue sampling bias was noted with either SB38 or SBU.
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- . SpeedBird needle tips continued to rotate throughout all powered passes in all tissue types and remained undistorted following all portions of the testing.
- . Motor torque and battery power remained adequate throughout the procedures, with no requirement to exchange batteries. No significant change in needle rotation speed observed.
Conclusions
Substantial equivalence to the identified predicate devices is based on the following:
- . Indications For Use: The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices have essentially the same indications for use as the identified predicate device Sanarus Cassi™ II Rotational Core Biopsy System (K051581). The other identified predicate devices have indications for use that are a subset of the indications for use for the SpeedBird Soft Tissue Biopsy Devices and the identified predicate device Sanarus Cassi™ II Rotational Core Biopsy System (K051581).
- . Technology characteristics: The device technology comparisons demonstrate that the design features, operational principles, patient contacting material composition, energy source, and other technological characteristics of the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are substantially equivalent to the identified predicate devices, with minor differences that do not raise any new questions of safety or effectiveness.
- . Performance testing: Performance testing of the SpeedBird Soft Tissue Biopsy Devices demonstrates that the SpeedBird devices perform substantially equivalently to the identified predicate devices, and that the features of the SpeedBird devices do not raise any new issues of safety and effectiveness.
The data provided in the 510(k) submission together support the determination that the SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are as safe, as effective, and perform substantially equivalently to the identified predicate devices.