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.

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 contains controls, a laser pointer, a specimen collection tube, a drive mechanism, a vacuum pump, a DC motor, a power indicator light, and batteries. The working end includes a stainless steel coring cannula with twin opposed cutter blades.

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 contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input. The working end includes a stainless steel coring cannula with twin opposed cutter blades.

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 contains a stainless steel coring cannula with twin opposed cutter blades, a detachable coaxial outer tube, and fluid transport tubing. The Biopsy Needle Handle (driver) contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the SpeedBird Soft Tissue Biopsy Devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" in a quantitative sense (e.g., minimum sensitivity/specificity). Instead, the performance testing focuses on demonstrating the device's functional equivalence to predicate devices and its ability to effectively perform its intended use. The criteria are indirectly inferred from the study endpoints.

Acceptance Criteria (Inferred)	Reported Device Performance
Effectiveness of tissue penetration, tissue sample part-off, and tissue transport across various tissue densities.	The SpeedBird devices effectively penetrated, cored, and severed all surrogate tissue types in both single and multiple sample modes.
Ability to obtain adequate tissue samples for histopathological evaluation.	All coring passes obtained consistent, predictable, undistorted (by unmagnified visual inspection) composite samples. Samples were full-diameter and ranged in length from 19mm to 46mm, producing corresponding volume measurements.
Effectiveness of tissue transport mechanisms (vacuum, fluid flush, transport pathway) for successful core collection.	Tissue transport via vacuum and the specimen collection tube was effective, leading to successful collection of tissue sample cores.
Condition of the needle tip after each sampling pass.	SpeedBird needle tips continued to rotate throughout all powered passes in all tissue types and remained undistorted following all portions of the testing.
Proper functioning of driving motor, gear power train, motor controls, and power source.	Motor torque and battery power remained adequate throughout the procedures, with no requirement to exchange batteries. No significant change in needle rotation speed observed.
Force of tissue penetration comparable to predicate devices.	Forces required to penetrate surrogate tissues remained low, with no significant change observed. SpeedBird devices performed substantially equivalently to predicate devices for force of penetration.
Absence of tissue sampling bias.	No tissue sampling bias was noted with either SB38 or SBU.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of patients or cases. The test set involved "surrogate tissues" representing a wide variety of tissue densities. The testing involved multiple passes and samples taken from these surrogates.
Data Provenance: The data is from "bench testing" using "surrogate tissues." This indicates it's an in-vitro (laboratory) study and does not involve human or animal data. The country of origin is not specified, but the submission is to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For bench testing with surrogate tissues, the "ground truth" is typically the physical measurement of the device's performance against predefined objectives (e.g., sample size, penetration force, integrity of the device). There's no mention of human expert consensus for "ground truth" in this context.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is bench testing, not a clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the SpeedBird device is a physical biopsy instrument, not an AI algorithm. If the question implies "device only" performance, then the bench testing effectively serves as a standalone performance evaluation of the device's mechanical and functional capabilities.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established through physical measurements and visual inspection of the device's performance on surrogate tissues, including:

Physical dimensions and integrity of the acquired tissue samples.
Measured forces of penetration.
Observed condition of the needle tip.
Verification of motor function and power.

This is distinct from pathology, expert consensus, or outcomes data, which are typically used for clinical diagnostic devices.

8. The Sample Size for the Training Set

This information is not applicable. The SpeedBird devices are mechanical medical devices, not AI/ML algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a mechanical device.

Summary

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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

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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)

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 RoadPortola Valley, CA 94028
Contact Person	James W. Vetter, MDChairman, TransMed7, LLCTelephone: 650-400-0101 Fax: 650-854-5910jvetter@transmed7.com
Date of Preparation	October 16, 2017
Trade Names	SpeedBird Model SB38 Soft Tissue Biopsy Device, SpeedBird Model SBUSoft Tissue Biopsy Device, and SpeedBird Model SBU99 Soft TissueBiopsy 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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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.

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).

1. 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
1. 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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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 ModelSB38, Model SBU,and Model SBU99Soft Tissue BiopsyDevices	The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devicesare intended for diagnostic sampling of soft tissue during soft tissue biopsyprocedures. They are to be used for diagnostic purposes only and are not intendedfor therapeutic uses.
	The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devicesare indicated to provide soft tissue samples for diagnostic sampling of soft tissueabnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, andvarious other soft tissue abnormalities. They are designed to provide soft tissue forhistologic examination, with partial or complete removal of the imaged abnormality.
	The extent of histologic abnormality cannot be reliably determined from imagingappearance (ultrasound, radiographic, e.g., mammographic) of a soft tissueabnormality. Therefore, the extent of removal of the imaged evidence of anabnormality does not predict the extent of removal of a histologic abnormality (e.g.,malignancy). When the sampled abnormality is not histologically benign, it isessential that the tissue margins be examined for completeness of removal usingstandard surgical procedures.
Magic™ BreastBiopsy DeviceK053151	The Rubicor Magic ™ Breast Biopsy Device is intended for diagnostic sampling ofbreast tissue during breast biopsy procedures. It is to be used for diagnostic purposesonly and is not intended for therapeutic uses.
	The Rubicor Magic ™ Breast Biopsy Device is indicated to provide breast tissuesamples for diagnostic sampling of breast abnormalities. It is designed to providebreast tissue for histologic examination with partial or complete removal of theimaged abnormality.
	The extent of histologic abnormality cannot be reliably determined from itsmammographic appearance. Therefore, the extent of removal of the imagedevidence of an abnormality does not predict the extent of removal of a histologicabnormality (e.g., malignancy). When the sampled abnormality is not histologicallybenign, it is essential that the tissue margins be examined for completeness ofremoval using standard surgical procedures.
Device	Indications For Use Statement
Sanarus Cassi™ IIRotational CoreBiopsy SystemK051581	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 notintended for use in bone.
	The device is also indicated to provide breast tissue samples for diagnostic samplingof breast abnormalities. It is designed to provide breast tissue for histologicexamination with partial or complete removal of the imaged abnormality.
	The extent of histologic abnormality cannot be reliably determined from itsmammographic appearance. Therefore, the extent of removal of the imagedevidence of an abnormality does not predict the extent of removal of a histologicabnormality (e.g., malignancy). When the sampled abnormality is not histologicallybenign, it is essential that the tissue margins be examined for completeness ofremoval using standard surgical procedures.
BIP VacuFlash®Biopsy SystemK024089	The BIP VacuFlash® Biopsy System is indicated to provide breast tissue samples fordiagnostic sampling of breast abnormalities. The instrument is designed to providebreast tissue for histologic examination with partial or complete removal of theimaged abnormality.
	The extent of histologic abnormality cannot be reliably determined from itsmammographic appearance. Therefore, the extent of removal of the imagedevidence of an abnormality does not predict the extent of removal of a histologicabnormality (e.g., malignancy). When the sampled abnormality is not histologicallybenign, it is essential that the tissue margins be examined for completeness ofremoval using standard surgical procedures.
Mammotome elite®Biopsy SystemK153709	The Mammotome elite® Biopsy System is indicated to obtain tissue samples from thebreast or axillary lymph nodes for diagnostic analysis of breast abnormalities. TheMammotome elite® Biopsy System is intended to provide breast tissue for histologicexamination with partial or complete removal of the imaged abnormality. TheMammotome elite® Biopsy System is intended to provide breast tissue for histologicexamination with partial removal of a palpable abnormality. The extent of a histologicabnormality cannot always be readily determined from the palpation or imagedappearance. Therefore, the extent of removal of the palpated or imaged evidence ofan abnormality does not predict the extent of removal of a histologic abnormality,e.g., malignancy. When the sample abnormality is not histologically benign, it isessential that the tissue margins be examined for completeness of removal usingstandard surgical procedures. In instances when a patient presents with a palpableabnormality that has been classified as benign through clinical and/or radiologicalcriteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy Systemmay also be used to partially remove such palpable lesions. Whenever breast tissue isremoved, histological evaluation of the tissue is the standard of care. When thesampled abnormality is not histologically benign, it is essential that the tissue marginsbe examined for completeness of removal using standard surgical procedures.

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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	SpeedBirdModel SB38	SpeedBirdModel SBUand SpeedBirdModel SBU99	Magic™BreastBiopsyDevice	SanarusCassi™ IIRotationalCore BiopsySystem	BIP®VacuFlashBiopsySystem	Mammotomeelite® BiopsySystem
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	SpeedBirdModel SB38	SpeedBirdModel SBUand SpeedBirdModel SBU99	Magic™BreastBiopsyDevice	SanarusCassi™ IIRotationalCore BiopsySystem	BIP®VacuFlashBiopsySystem	Mammotomeelite® BiopsySystem
Method oftissue collection	Vacuum,through tospecimencollectiontube	Vacuum,through tospecimencollection tube	Retentionfinger,transporttube,ejectionpin	Freezingneedlesurroundedby outerrotatingcutter	Side troughsurroundedby outerround cutter	Vacuum,transporttube, ejectionpin
Patientcontactingmaterials	Stainlesssteel;surgical-gradeplastic	Stainless steel;surgical-gradeplastic	Stainlesssteel	Stainlesssteel	Stainlesssteel;surgical-grade plastic	Stainless steel
Power source	DC Motor;Internal built-in batterypower (3Vbatteries)	DC Motor;Connectionsfor an externalbattery packor atransformerpower sourceas desired	DC Motor,9V battery	DC motor,compressedgas, 9vbattery	DC Motor,rechargeablebattery	DC Motor,110V AC
Hand-heldprocedure ?	Yes	Yes	Yes	Yes	Yes	Yes
Single usedisposabledevice vs.reusable device	Single use,fullydisposable	Model SBU:Single use,fullydisposableModel SBU99:Single use,disposablebiopsy needle;reusablehandle (driver)	Single use,fullydisposable	Single use,disposablebiopsyneedle(probe);reusablehandle(driver)	Single use,disposablebiopsyneedle(probe);reusablehandle(driver)	Single use,disposablebiopsy needle(probe);reusablehandle(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.

Regulation Number and Section

§ 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.