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 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.

AI/ML Overview

The information provided describes a medical device, the TeesuVac Breast Biopsy Device Mark 1, and its substantial equivalence to a predicate device (Bard Max-Core Disposable Core Biopsy Instrument) based on non-clinical testing. It does not contain information about clinical studies with human participants, AI performance, or ground truth established by experts.

Therefore, many of the requested sections about acceptance criteria, efficacy studies, and ground truth cannot be filled from the provided text.

Here's the available information based on the document:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison of attributes between the subject device (TeesuVac Breast Biopsy Device Mark 1) and the predicate device (Bard Max-Core, K133948). The "Evaluation" column in the table suggests that the subject device's performance is considered "Similar" or "Same as" the predicate device for most attributes, indicating that meeting these comparable performance characteristics serves as the de facto acceptance criteria for "substantial equivalence."

Attribute	Acceptance Criteria (Implicit: Similar to/Same as Predicate)	Reported Device Performance (Subject Device)
Device Type	Biopsy Instrument	Biopsy Instrument
Regulation Number	21 CFR 876.1075	21 CFR 876.1075
Product Code	KNW	KNW
Indication for Use	Similar to Bard Max-Core (broader for predicate)	To obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast (diagnostic use only)
Patient Population	Similar to Bard Max-Core	Any patient population requiring the harvest of cellular material
Disposable	Single-use	Single-use
SAL level	SAL > 10^-6	SAL > 10^-6
Sterilization method	Similar to Bard Max-Core	Gamma
Visualization Techniques	Similar to Bard Max-Core (predicate has more options)	Ultrasound Imaging
Principle of Operation	Similar to Bard Max-Core	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.
Materials	A single-use device composed primarily of plastics and stainless steel	A single-use device composed primarily of plastics and stainless steel
Patient contacting materials	Stainless steel needle (and rarely the plastic handle)	Stainless steel needle (and rarely the plastic handle)
Mechanical principle	Similar to Max-Core (predicate is not electromechanical)	Self-contained handheld electromechanical vacuum-assisted biopsy device
Number of tissue samples	Single sample per puncture	Single sample per puncture
Mechanism of action	Similar to Bard Max-Core	Outer tube retracts, then moves forward
Mode of action	Fast-moving outer tube	Fast-moving outer tube
Needle Design	Separated Coaxial Cannula, Hollow outer cutting cannula, Notched inner needle/trocar 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
Needle diameter/gauge	14G	14G
Number of samples	Single sample per puncture	Single sample per puncture
Sample weight	~10 mg (Pig breast)	14 mg (Pig Breast)
Sample Length	~8.35 mm (Pig breast)	9.04 mm (Pig breast)
Number of segments in samples	Minimum 1.2, Maximum 2.1 segments	Minimum 1 segment, Maximum 2.1 segments
Sample Quality score	4.86	7.71
Durability	≥ 5 shots, Intact needle tip	≥ 5 shots, Intact needle tip
Duration of the sample cut	< 1 second	< 1 second
Firing Distance (Needle Advancement)	22mm (piercing)	21.5 mm (Steady cut)
Power source	NA (Mechanical only for predicate)	Low Voltage VDC motor
Energy Used/Delivered	NA (Mechanical, delivered by manual operation for predicate)	Direct Current from Battery
Stroke/Travel length outer tube	22 mm	21.5 mm
Penetration (Initial Penetration Force)	1.0 N	0.8 N
Penetration Force - Pear (depth of 12.5 mm)	5.6 N	6.1 N
Bending load (Deflection at 40 N < 0.4 mm)	0.19 mm	0.29 mm
Probe tip welding strength	Resistance to 100N: Yes	Resistance to 100N: Yes
Operated by either hand	Right or left	Right or left
Packaging materials	PET, and Tyvek	PET, Tyvek, and LDPE

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "in-vitro device performance," "electrical & product safety," "sterilization," "biocompatibility," "predicate device comparison," and "simulated use testing." The specific sample sizes for these non-clinical tests are not provided. The data provenance is also not specified (country of origin, retrospective/prospective). The sample weight, length, and number of segments are reported for "Pig breast," indicating animal tissue was used for some performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document discusses device performance and comparison to a predicate, not diagnostic accuracy based on expert interpretation. No ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a medical device for obtaining biopsy specimens, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance metrics like sample weight, length, number of segments, and quality score, the "ground truth" would be the objective measurements obtained from the biopsy samples taken from "Pig breast." This is a form of objective measurement/laboratory data from a biological model, not expert consensus or pathology on human samples in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a physical device, and the testing described is non-clinical performance evaluation, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable. (See #8).

Summary

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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 (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 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: +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

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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 DEVICEBard Max-Core(K133948)	SUBJECT DEVICETeesuVac Breast Biopsy DeviceMark 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 biopsydevice is intended for usein obtaining biopsies fromsoft tissues such as theliver, kidney, prostate,spleen, lymph nodes, andvarious soft tissuetumors. It is not intendedfor use in bone.	The TeesuVac Breast BiopsyDevice Mark 1 is indicated toobtain percutaneous corebiopsy specimens from softtissue and tumors of thebreast. This product isintended for diagnostic useonly, NOT therapeutictherapy. The instrument isintended to provide breasttissue for histologicexamination with partial orcomplete removal of theimaged abnormality.The extent of histologicabnormality cannot bereliably determined from itsmammographic appearance.Therefore, the extent ofremoving the imagedevidence of an abnormalitydoes not predict the extent ofremoval of a histologicabnormality (e.g.,malignancy). When thesampled abnormality is nothistologically benign, thetissue margins must be	Similar to BardMax-Core.However, BardMax-Core has abroader indicationfor use
#	Attribute	PREDICATE DEVICEBard Max-Core(K133948)	SUBJECT DEVICETeesuVac Breast Biopsy DeviceMark 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	VisualizationTechniques	X-ray, ultrasound, CT, etc.	Ultrasound Imaging	Similar Bard Max-Core. However, Bard Max-Core can be applied to several visualizations' techniques
10	Principle ofOperation	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 contactingmaterials	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 tissuesamples	Single sample per puncture	Single sample per puncture	Same as Bard Max-Core
15	Mechanism of action	The inner tube moves forwardThe outer tube moves forward	Outer tube retractsThe 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 DeviceMark 1 (K212079)	Evaluation
17	Needle Design	• Separate CoaxialCannula• Hollow outer cuttingcannula.• Hollow notched innerneedle/bevel tipped, notransport of tissue.• Aspiration via innerneedle	• Separated Coaxial Cannula• Hollow outer cuttingcannula• Notched innerneedle/trocar tipped, notransport of tissue• Aspiration via inner needle	Same as BardMax-Core
18	Needlediameter/gauge	14G	14G	Same as BardMax- Core
19	Number of samples	Single sample perpuncture	Single sample per puncture	Same as BardMax-Core
20	Sample weight	10 mg (Pig breast)	14 mg (Pig Breast)	Similar to BardMax-Core
21	Sample Length	8,35 mm (Pig breast)	9,04 mm (Pig breast)	Similar to BardMax-Core but haveno impact onsafety
22	Number ofsegments insamples	Minimum 1,2 segments,Maximum 2,1 segments	Minimum 1 segment,Maximum 2,1 segments	Similar to BardMax-Core but haveno impact onsafety
23	Sample Qualityscore	4,86	7,71	Similar to BardMax-Core but haveno impact onsafety
24	Durability	≥ 5 shotsIntact needle tip	≥ 5 shotsIntact needle tip	Same as BardMax-Core
25	Duration of thesample cut	< 1 second	< 1 second	Same as BardMax-Core
26	Firing Distance(NeedleAdvancement(piercing) or noAdvancement(Steady cut))	22mm (piercing)	21,5 mm (Steady cut)	Similar to BardMax-Core but haveno impact onsafety
27	Power source	NA (Mechanical only)	Low Voltage VDC motor	Similar to BardMax-Core but haveno impact onsafety
28	EnergyUsed/Delivered	NA (Mechanical, deliveredby a manual operation)	Direct Current from Battery	Similar to Max-Core but have noimpact on safety
29	Stroke/Travellength outer tube	22 mm	21,5 mm	Similar to BardMax-Core but haveno impact onsafety
#	Attribute	PREDICATE DEVICEBard Max-Core(K133948)	SUBJECT DEVICETeesuVac Breast Biopsy DeviceMark 1 (K212079)	Evaluation
30	Penetration (InitialPenetration Force)	1,0 N	0,8 N	Similar to BardMax-Core but haveno impact onsafety
31	Penetration Force -Pear (depth of 12,5mm)	5,6 N	6,1 N	Similar to BardMax-Core but haveno impact onsafety
32	Bending load(Deflection at 40 N<0,4 mm)	0,19 mm	0,29 mm	Similar to BardMax-Core but haveno impact onsafety
33	Probe tip weldingstrengthResistance to 100N	Yes	Yes	Same as BardMax-Core
34	Operated by eitherhand	Right or left	Right or left	Same as BardMax-Core
35	Packaging materials	PET, and Tyvek	PET, Tyvek, and LDPE	Similar to BardMax-Core but hasno impact onsafety

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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.

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.