TeesuVac Breast Biopsy Device Mark 1

K212079 · Teesuvac Aps · KNW · Feb 2, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K212079
• Device Name: TeesuVac Breast Biopsy Device Mark 1
• Applicant: Teesuvac Aps
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended 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.

Device Story

TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless, handheld, battery-driven, vacuum-assisted biopsy device for single-patient use. Operated by a physician under ultrasound guidance, it harvests percutaneous core biopsy specimens from breast soft tissue and tumors. The device features a 14G needle set with an inner cannula (specimen chamber) and a sharp outer cutting cannula. Operation involves a slider for loading and a sampling button; a low-voltage DC motor drives the mechanism. During sampling, vacuum pulls tissue into the chamber, and the outer cannula moves forward to cut and collect the specimen. The device is intended for diagnostic purposes only. Output is a tissue sample for histologic examination, aiding clinical diagnosis of breast abnormalities. It provides a minimally invasive method for tissue acquisition.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing only, including in-vitro device performance, electrical and product safety (IEC 60601-1, 60601-1-2), sterilization validation, biocompatibility, and simulated use testing (pig breast model).

Technological Characteristics

Single-use, handheld, electromechanical vacuum-assisted biopsy device. Materials: Stainless steel AISI 304 (needle), plastics (handle). Energy source: Low voltage DC battery. Dimensions: 14G needle. Sterilization: Gamma. Connectivity: None. Software: None (electromechanical).

Indications for Use

Indicated for obtaining percutaneous core biopsy specimens from soft tissue and tumors of the breast for diagnostic histologic examination. Intended for professional use only. Not for therapeutic use.

Regulatory Classification

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.

Predicate Devices

• Bard Max-Core Disposable Core Biopsy Instrument (K133948)

Submission Summary (Full Text)

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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

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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 [phone] 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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### 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: [phone] Telefax: N/A Email: [e-mail] Website: www.teesuvac.com

# Contact

Mr. John Hvidkjaer CEO TeesuVac ApS Agern Allé 3 2970 Hoersholm Denmark Phone: [phone] 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

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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<br>Bard Max-Core<br>(K133948) | SUBJECT DEVICE<br>TeesuVac Breast Biopsy Device<br>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<br>device is intended for use<br>in obtaining biopsies from<br>soft tissues such as the<br>liver, kidney, prostate,<br>spleen, lymph nodes, and<br>various soft tissue<br>tumors. It is not intended<br>for use in bone. | The TeesuVac Breast Biopsy<br>Device Mark 1 is indicated to<br>obtain percutaneous core<br>biopsy specimens from soft<br>tissue and tumors of the<br>breast. This product is<br>intended for diagnostic use<br>only, NOT therapeutic<br>therapy. The instrument is<br>intended to provide breast<br>tissue for histologic<br>examination with partial or<br>complete removal of the<br>imaged abnormality.<br>The extent of histologic<br>abnormality cannot be<br>reliably determined from its<br>mammographic appearance.<br>Therefore, the extent of<br>removing the imaged<br>evidence of an abnormality<br>does not predict the extent of<br>removal of a histologic<br>abnormality (e.g.,<br>malignancy). When the<br>sampled abnormality is not<br>histologically benign, the<br>tissue margins must be | Similar to Bard<br>Max-Core.<br>However, Bard<br>Max-Core has a<br>broader indication<br>for use |
| # | Attribute | PREDICATE DEVICE<br>Bard Max-Core<br>(K133948) | SUBJECT DEVICE<br>TeesuVac Breast Biopsy Device<br>Mark 1 (k212079)<br>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<br>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<br>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<br>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<br>samples | Single sample per puncture | Single sample per puncture | Same as Bard Max-Core |
| 15 | Mechanism of action | The inner tube moves forward<br>The outer tube moves forward | Outer tube retracts<br>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<br>(K133948) | TeesuVac Breast Biopsy Device<br>Mark 1 (k212079) | Evaluation |
| 17 | Needle Design | • Separate Coaxial<br>Cannula<br>• Hollow outer cutting<br>cannula.<br>• Hollow notched inner<br>needle/bevel tipped, no<br>transport of tissue.<br>• Aspiration via inner<br>needle | • Separated Coaxial Cannula<br>• Hollow outer cutting<br>cannula<br>• Notched inner<br>needle/trocar tipped, no<br>transport of tissue<br>• Aspiration via inner needle | Same as Bard<br>Max-Core |
| 18 | Needle<br>diameter/gauge | 14G | 14G | Same as Bard<br>Max- Core |
| 19 | Number of samples | Single sample per<br>puncture | Single sample per puncture | Same as Bard<br>Max-Core |
| 20 | Sample weight | 10 mg (Pig breast) | 14 mg (Pig Breast) | Similar to Bard<br>Max-Core |
| 21 | Sample Length | 8,35 mm (Pig breast) | 9,04 mm (Pig breast) | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 22 | Number of<br>segments in<br>samples | Minimum 1,2 segments,<br>Maximum 2,1 segments | Minimum 1 segment,<br>Maximum 2,1 segments | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 23 | Sample Quality<br>score | 4,86 | 7,71 | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 24 | Durability | ≥ 5 shots<br>Intact needle tip | ≥ 5 shots<br>Intact needle tip | Same as Bard<br>Max-Core |
| 25 | Duration of the<br>sample cut | < 1 second | < 1 second | Same as Bard<br>Max-Core |
| 26 | Firing Distance<br>(Needle<br>Advancement<br>(piercing) or no<br>Advancement<br>(Steady cut)) | 22mm (piercing) | 21,5 mm (Steady cut) | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 27 | Power source | NA (Mechanical only) | Low Voltage VDC motor | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 28 | Energy<br>Used/Delivered | NA (Mechanical, delivered<br>by a manual operation) | Direct Current from Battery | Similar to Max-<br>Core but have no<br>impact on safety |
| 29 | Stroke/Travel<br>length outer tube | 22 mm | 21,5 mm | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| # | Attribute | PREDICATE DEVICE<br>Bard Max-Core<br>(K133948) | SUBJECT DEVICE<br>TeesuVac Breast Biopsy Device<br>Mark 1 (k212079) | Evaluation |
| 30 | Penetration (Initial<br>Penetration Force) | 1,0 N | 0,8 N | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 31 | Penetration Force -<br>Pear (depth of 12,5<br>mm) | 5,6 N | 6,1 N | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 32 | Bending load<br>(Deflection at 40 N<br><0,4 mm) | 0,19 mm | 0,29 mm | Similar to Bard<br>Max-Core but have<br>no impact on<br>safety |
| 33 | Probe tip welding<br>strength<br>Resistance to 100N | Yes | Yes | Same as Bard<br>Max-Core |
| 34 | Operated by either<br>hand | Right or left | Right or left | Same as Bard<br>Max-Core |
| 35 | Packaging materials | PET, and Tyvek | PET, Tyvek, and LDPE | Similar to Bard<br>Max-Core but has<br>no impact on<br>safety |

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#### Similarities between the TeesuVac Breast Biopsy Device Mark 1 and the predicate device(s):

- Same Device type, Regulation number, and Product code *
- Similar indications for use *
- Similar Patient population *
- Similar fundamental scientific technology *
- * Similar operating principle
- Single-use device *
- The same number of samples per incision *
- Similar needle material, design, and gauge *
- Similar weight mass of the sample size *
- Similar length *
- A similar number of segments 米
- Similar Sample Quality score *
- The same durability and needle tip intact *
- Similar penetration force, initially and in-depth 米
- * Same packaging materials
- * Similar sterility assurance level and method of sterilization

The only directly patient contacting material is the needle, and all the needles are made of Stainless steel AISI 304, which is the same material.

#### Differences between the TeesuVac Breast Biopsy Device Mark 1 and the predicate device:

The mechanical principle of the Bard Max-Core is a self-contained handheld mechanical spring-loaded biopsy device. The TeesuVac Breast Biopsy Device Mark 1 is a self-contained handheld electromechanical spring-loaded vacuum-assisted biopsy device energized by a

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motor powered by low voltage batteries (power supply). However, both the TeesuVac Breast Biopsy Device Mark 1 and the Bard Max-Core are essentially performing the sample harvesting utilizing springs that have been compressed. Whether the springs have been compressed by manual force or electromechanically driven force is insignificant. It is still similar regarding the sample, and thus no difference concerning safety and effectiveness.

The mechanism of action and mode of action of the TeesuVac Breast Biopsy Device Mark 1 is that the outer tube retracts to open the tissue chamber and subsequently moves forward to harvest the sample. The Bard Max-Core has a piercing shot where the inner core moves forward to open the tissue chamber, and the outer tube subsequently moves forward to harvest the sample. However, the TeesuVac Breast Biopsy Device Mark 1 is additionally vacuum-assisted. The Bard Max-Core and TeesuVac Breast Biopsy Device Mark 1 have fast-moving outer tubes that harvest the sample. The Bard Max-Core and TeesuVac Breast Biopsy Device Mark 1 are therefore comparable in their cutting method. The tissue samples' weight is comparable to that of the predicate device. There are no differences concerning vacuum-assisted and core needle devices reqarding safety and effectiveness.

### Testing Summary:

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.

#### Conclusion

The proposed TeesuVac Breast Biopsy Device Mark 1 (k212079) is substantially equivalent to the predicate device Bard Max-Core Disposable Core Biopsy Instrument (k133948).

The differences between the proposed and predicate devices do not impact the safety and effectiveness of the proposed device. Performance testing supports that the proposed device is substantially equivalent to the legally marketed predicate device.