(215 days)
Not Found
No
The 510(k) summary describes a mechanical vacuum-assisted biopsy device. There is no mention of AI, ML, image processing for analysis, or any software components that would suggest the use of such technologies. The performance studies focus on mechanical and safety aspects, not algorithmic performance.
No
The "Intended Use / Indications for Use" section explicitly states, "This product is intended for diagnostic use only, NOT therapy." and the "Device Description" section reiterates, "TeesuVac Breast Biopsy Device Mark 1 is intended for biopsy and diagnosis only."
Yes
The document explicitly states multiple times that the device is "intended for diagnostic use only," "intended to provide breast tissue for histologic examination," and "intended for biopsy and diagnosis only." These phrases directly indicate its role in diagnosis.
No
The device description explicitly states it is a "sterile, tetherless vacuum-assisted handheld biopsy device" that is "battery-driven" and "fitted with a 14G needle set." This indicates it is a physical hardware device, not software only.
Based on the provided information, the TeesuVac Breast Biopsy Device Mark 1 is not an In Vitro Diagnostic (IVD) device itself.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes.
- TeesuVac's Function: The TeesuVac device is a tool used to obtain the tissue specimen from the breast in vivo (within the body). It is a biopsy device, a surgical instrument used for tissue collection.
- Diagnostic Use of the Tissue: The description clearly states that the tissue harvested by the TeesuVac is intended for diagnostic use, meaning it will be examined after it's collected, likely using IVD methods (like histology, pathology, etc.).
In summary, the TeesuVac is a device that enables in vitro diagnostic procedures by providing the necessary sample, but it does not perform the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapy. The instrument is intended 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 removing 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
TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless vacuum-assisted handheld biopsy device intended to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast with ultrasound guidance. TeesuVac Breast Biopsy Device Mark 1 is intended for biopsy and diagnosis only. The device is battery-driven and for single-patient use. An unsterilized Battery Pack that comes with the biopsy device is applied using the sterile Battery Clip, stored in the tray containing the biopsy device. The device is fitted with a 14G needle set to obtain specimens from soft tissue and tumors. The device is for professional users only. The tissue harvested by TeesuVac Breast Biopsy Device Mark 1 is intended for diagnostic use only.
The cannula needle consists of two hollow cannulas, an inner cannula with a specimen chamber, and a sharp outer cutting cannula that extends at high speeds over the aperture to acquire targeted tissue specimens. During the shot, a vacuum pulls the tissue into the chamber, followed by moving the outer cutting cannula forward over the specimen chamber to cut the tissue and collect the specimen in the specimen chamber. The TeesuVac Breast Biopsy Device Mark 1 has two buttons: the Slider for loading and the Sampling button to perform the biopsy procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound Imaging
Anatomical Site
soft tissue, and tumors of the breast
Indicated Patient Age Range
Any patient population requiring the harvest of cellular material
Intended User / Care Setting
professional users only.
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)
The TeesuVac Breast Biopsy Device Mark 1 was evaluated in the following non-clinical studies: in-vitro device performance, electrical & product safety (IEC 60601-1, 60601-1-2), sterilization, biocompatibility, predicate device comparison, and simulated use testing.
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.
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.
0
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February 2, 2022
TeesuVac ApS Mr. John Hvidkjaer CEO Agern Alle 3 2970 Hoersholm Denmark
Re: K212079
Trade/Device Name: Teesu Vac Breast Biopsv Device Mark 1 Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: December 30, 2021 Received: January 5, 2022
Dear Mr. Hvidkjaer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212079
Device Name TeesuVac Breast Biopsy Device Mark 1
Indications for Use (Describe)
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapy. The instrument is intended 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 removing 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 essue margins be examined for completeness of removal using standard surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety and Effectiveness 21 CFR 807.92 TeesuVac Breast Biopsy Device Mark 1 (K212079)
Traditional 510k
Date Summary Prepared
February 1st, 2022
Submitter's Identification
TeesuVac ApS Agern Allé 3 2970 Hoersholm Denmark Phone: +45 6155 8399 Telefax: N/A Email: jhv@teesuvac.com Website: www.teesuvac.com
Contact
Mr. John Hvidkjaer CEO TeesuVac ApS Agern Allé 3 2970 Hoersholm Denmark Phone: +45 6155 8399 Telefax: N/A
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Device
Common Name: Vacuum-Assisted Biopsy Device Regulatory Class: II Classification: 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument Product Code: KNW
Predicate Device
Predicate #1:
Trade/Proprietary Name: Bard Max-Core Disposable Core Biopsy Instrument Premarket Notification: K133948 Manufacturer: Bard Peripheral Vascular, Inc
TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless vacuum-assisted handheld biopsy device intended to obtain percutaneouscore biopsy specimens from soft tissue and tumors of the breast with ultrasound quidance. TeesuVac Breast Biopsy Device Mark 1 is intended for biopsy and diagnosis only. The device isbattery-driven and for single-patient use. An unsterilized Battery Pack that comes with the biopsy device is applied using the sterile Battery Clip, stored in the tray containing the biopsy device. The device is fitted with a 14G needle set to obtain specimens from soft tissue and tumors. The device is for professional users only. The tissue harvested by TeesuVac Breast Biopsy Device Mark 1 is intended for diagnostic use only.
The cannula needle consists of two hollow cannulas, an inner cannula with a specimen chamber, and a sharp outer cutting cannula that extends at high speeds over the aperture to acquire targeted tissue specimens. During the shot, a vacuum pulls the tissue into the chamber, followed by movingthe outer cutting cannula forward over the specimen chamber to cut the tissue and collect the specimen in the specimen chamber. The TeesuVac Breast Biopsy Device Mark 1 has two buttons: the Slider for loading and the Sampling button to perform the biopsy procedure.
Indications for use
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast. This product is intended for diagnostic use only, NOT therapeutic therapy. The instrument is intended 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 removing theimaged 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
5
examined for completeness of removal using standard surgical procedures.
Summary of the technological characteristics of the device compared to the predicate device
TeesuVac Breast Biopsy Device Mark 1 is identical in terms of indications for use and the technology to the Bard Max-Core Disposable Core Biopsy Instrument manufactured by Bard Peripheral Vascular, Inc, whose predicate device is currently in commercial distribution and US-FDA cleared under K133948.
Table 1 below summarizes the technological characteristics of TeesuVac Breast Biopsy Device Mark 1 vs. the predicate device.
| # | Attribute | PREDICATE DEVICE
Bard Max-Core
(K133948) | SUBJECT DEVICE
TeesuVac Breast Biopsy Device
Mark 1 (K212079) | Evaluation |
|----|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 1 | Device Type | Biopsy Instrument | Biopsy Instrument | Same as Bard Max-Core |
| 2 | Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | Same as Bard Max-Core |
| 3 | Product code | KNW | KNW | Same as Bard Max-Core |
| 4 | Indication for Use | The Core needle biopsy
device is intended for use
in obtaining biopsies from
soft tissues such as the
liver, kidney, prostate,
spleen, lymph nodes, and
various soft tissue
tumors. It is not intended
for use in bone. | The TeesuVac Breast Biopsy
Device Mark 1 is indicated to
obtain percutaneous core
biopsy specimens from soft
tissue and tumors of the
breast. This product is
intended for diagnostic use
only, NOT therapeutic
therapy. The instrument is
intended 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
removing 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, the
tissue margins must be | Similar to Bard
Max-Core.
However, Bard
Max-Core has a
broader indication
for use |
| # | Attribute | PREDICATE DEVICE
Bard Max-Core
(K133948) | SUBJECT DEVICE
TeesuVac Breast Biopsy Device
Mark 1 (K212079)
examined for completeness of removal using standard surgical procedures. | Evaluation |
| 5 | Patient Population | Individuals requiring biopsy for a sampling of soft tissue abnormalities | Any patient population requiring the harvest of cellular material | Similar to Bard Max-Core but has no impact on safety |
| 6 | Disposable | Single-use | Single-use | Same as Bard Max-Core |
| 7 | SAL level | SAL > 10-6 | SAL > 10-6 | Same as Bard Max-Core |
| 8 | Sterilization method | Ethylene Oxide | Gamma | Similar to Bard Max-Core, but have no impact on safety |
| 9 | Visualization
Techniques | X-ray, ultrasound, CT, etc. | Ultrasound Imaging | Similar Bard Max-Core. However, Bard Max-Core can be applied to several visualizations' techniques |
| 10 | Principle of
Operation | Prepare the site as required. Insert the tip of the needle and advance to the desired location. For ease of insertion, puncture the skin with a scalpel at the entry site. | Make a small incision or puncture the skin with a scalpel. Using ultrasound guidance, insert the needle through the incision, and position the tip to the appropriate depth. | Similar to Bard Max-Core but have no impact on safety |
| 11 | Materials | A single-use device composed primarily of plastics and stainless steel | A single-use device composed primarily of plastics and stainless steel | Same as Bard Max-Core |
| 12 | Patient contacting
materials | Stainless steel needle (and rarely the plastic handle) | Stainless steel needle (and rarely the plastic handle) | Same as Bard Max-Core |
| 13 | Mechanical principle | A self-contained handheld mechanical spring-loaded biopsy device | A self-contained handheld electromechanical vacuum-assisted biopsy device | Similar to Max-Core. Max-Core is not electromechanical, but it has no impact on safety |
| 14 | Number of tissue
samples | Single sample per puncture | Single sample per puncture | Same as Bard Max-Core |
| 15 | Mechanism of action | The inner tube moves forward
The outer tube moves forward | Outer tube retracts
The outer tube moves forward | Similar to Bard Max-Core but have no impact on safety |
| 16 | Mode of action | Fast-moving outer tube | Fast-moving outer tube | Same as Bard Max-Core |
| | | PREDICATE DEVICE | SUBJECT DEVICE | |
| # | Attribute | Bard Max-Core
(K133948) | TeesuVac Breast Biopsy Device
Mark 1 (K212079) | Evaluation |
| 17 | Needle Design | • Separate Coaxial
Cannula
• Hollow outer cutting
cannula.
• Hollow notched inner
needle/bevel tipped, no
transport of tissue.
• Aspiration via inner
needle | • Separated Coaxial Cannula
• Hollow outer cutting
cannula
• Notched inner
needle/trocar tipped, no
transport of tissue
• Aspiration via inner needle | Same as Bard
Max-Core |
| 18 | Needle
diameter/gauge | 14G | 14G | Same as Bard
Max- Core |
| 19 | Number of samples | Single sample per
puncture | Single sample per puncture | Same as Bard
Max-Core |
| 20 | Sample weight | 10 mg (Pig breast) | 14 mg (Pig Breast) | Similar to Bard
Max-Core |
| 21 | Sample Length | 8,35 mm (Pig breast) | 9,04 mm (Pig breast) | Similar to Bard
Max-Core but have
no impact on
safety |
| 22 | Number of
segments in
samples | Minimum 1,2 segments,
Maximum 2,1 segments | Minimum 1 segment,
Maximum 2,1 segments | Similar to Bard
Max-Core but have
no impact on
safety |
| 23 | Sample Quality
score | 4,86 | 7,71 | Similar to Bard
Max-Core but have
no impact on
safety |
| 24 | Durability | ≥ 5 shots
Intact needle tip | ≥ 5 shots
Intact needle tip | Same as Bard
Max-Core |
| 25 | Duration of the
sample cut |