The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles and liver. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures. The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

Device Description

The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body. The Coramate/Spirotome system consists of 2 major components: the set of needles (Spirotome) and a powered device that operates the needles (Coramate). The set of needles can be operated manually as well (single-use and reusable Spirotome). The needle set contains 3 needles that work in conjunction.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Coramate/Spirotome system, a mechanical biopsy device. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in a quantitative manner as typically expected for AI/ML device performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and states that "Thorough preclinical testing was performed to ensure the device performs as intended" and "Clinical testing indicates that all performance and safety aims are reached." It's a qualitative assertion rather than a presentation of specific metrics.

Therefore, for many of the requested items, the information is either not present or cannot be inferred from the provided document.

Here's a breakdown based on the request and the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific percentage of adequate samples, or a particular diagnostic accuracy). The overarching "acceptance criteria" appear to be that the device performs "as intended" with "aimed performance and maximal safety," similar to predicate devices, and without complications.

Reported Device Performance:

Performance Aspect	Reported Performance
Tissue Sampling Adequacy	"adequate samples" for histological and biomolecular detection and confirmation of abnormalities (as stated in the Indications for Use). The document asserts that the system performs "as intended" and provides "adequate sampling of human tissue... to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion."
Safety	"maximal safety" and "no complication was noted up to now in the clinical tests and subsequent vigilance quality control follow-up."
Clinical Equivalence	Performs "similar to the 'Indications for Use' of the predicate device." "Substantially equivalent" to the predicate devices and existing macrobiopsy systems (K060384). Meets "aims" of performance and safety.

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

Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or patients from a defined clinical study. The document mentions "clinical tests" and "clinical international + LLN relating to the performance in various other soft tissues than the breast," but no numbers are provided.
Data Provenance: The document states that "Most of the clinical work has been done in human breast tissues as has been published in international PEER reviewed Journals and Meetings. In addition, recent clinical international + LLN relating to the performance in various other soft tissues than the breast." This implies prospective and/or retrospective clinical data from multiple international sources, but no specific countries or study designs are elaborated.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It can be inferred that experts in pathology or relevant medical specialties would be involved in assessing the biopsy samples, but no details are given.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, this type of study is not mentioned as this device is a physical biopsy instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results with or without AI assistance.

6. Standalone Performance Study

Standalone Performance: Not applicable in the context of an AI algorithm. The performance described relates to the device's ability to extract adequate tissue samples, which is inherent to the device's mechanical function, not an algorithm running independently. The "clinical testing" mentioned is the closest equivalent, demonstrating the device's performance in a real-world setting.

7. Type of Ground Truth Used

Ground Truth: The primary ground truth for the performance of a biopsy device is the histological and biomolecular analysis of the tissue samples obtained. The text repeatedly mentions the device's intention "to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities" and "to make a reliable diagnosis of benignancy or malignancy." This implies the ground truth is established through laboratory analysis of the collected tissue.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical biopsy tool, not an AI/ML algorithm that requires a "training set."

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

Ground Truth for Training Set: Not applicable, as there is no AI/ML training set.

Summary

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APR 11 2008

510 (k) Summary

Medinvents NV 510 (k) Premarket Notification for Coramate/Spirotome K080095

Premarket Notification 510(k) Summary

(per 21 CFR 807.92) Coramate/Spirotome System Submitted by: Magda Buttiens CEO Medinvents B-3500 Hasselt - Belgium

Phone: +3211271557 Fax: +3211283677 Email: magda.buttiens@medinvents.com

Date prepared: February 25, 2008 Device Name: Trade Name: Coramate/Spirotome system Classification Name: Biopsy Needle

Predicate Devices:

Organ	Predicate device	ID-PD	510 (k) application	Remarks
Skin	Punch Biopsy needle	K896303	Spirotome (Easy Punch)
Vulva	Punch Biopsy needle	K896030	Spirotome (Easy Punch)
Breast	Mammotome	K033700	Spirotome/Coramate	K060384
Lymph node	Tru-cut needle	K024120	Spirotome/Coramate
Thyroid, salivary gland	Tru-cut needle	K024120	Spirotome/Coramate
Salivary gland	Tru-cut needle	K024120	Spirotome/Coramate
Liver	Tru-cut needle	K024120	Spirotome/Coramate
Cervix	Forceps	K842112	Spirotome Cervicore
Muscle	Tru-cut needle	K024120	Spirotome/Coramate
Abdominal wall	Tru-cut needle	K024120	Spirotome/Coramate
Thoracic wall	Tru-cut needle	K024120	Spirotome/Coramate
Bone	Bone marrow biopsy needle	K001132	Spirotome Bone

Device Description:

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Intended Use

Device Name	Indications for Use
Coramate system	The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequatesamples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall andparotis.The Coramate system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of imaged abnormalities.The Coramate system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of palpable abnormalities.An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignantdisease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis ofbenignancy or malignancy and to characterize as complete as possible the nature of the lesion withoutunnecessary discomfort to the patient.In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/orhormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can beprovided.
Spirotome system	The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take outadequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymphnodes, thyroid, parotis, muscles and liver.The Spirotome system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of imaged abnormalities.The Spirotome system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of palpable abnormalities.An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignantdisease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis ofbenignancy or malignancy and to characterize as complete as possible the nature of the lesion withoutunnecessary discomfort to the patient.In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/orhormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can beprovided.
Cervicore system	The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take outadequate samples of tissue from the human cervix.The Cervicore system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of imaged abnormalities by inspection or colposcopy.The Cervicore system is intended to provide soft tissue for histological and biomolecular detection andconfirmation of palpable abnormalities.An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignantdisease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis ofbenignancy or malignancy and to characterize as complete as possible the nature of the lesion withoutunnecessary discomfort to the patient.In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/orhormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can beprovided.
Easy Punch Spirotome	The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take outadequate samples of tissue from the skin.The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmationof imaged abnormalities.The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmationof palpable abnormalities.An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignantdisease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis ofbenignancy or malignancy and to characterize as complete as possible the nature of the lesion withoutunnecessary discomfort to the patient.In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/orhormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can beprovided.
Spirotome Bone	The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take outadequate samples of soft tissue from bony structures.The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection andconfirmation of imaged abnormalities.An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignantdisease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis ofbenignancy or malignancy and to characterize as complete as possible the nature of the lesion withoutunnecessary discomfort to the patient.In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/orhormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can beprovided.

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Ko80095

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Technological Characteristics

The Coramate/Spirotome system is identical to the currently marketed macrobiopsy systems (K060384). It contains a needle set and a hand held powered device based on the same concept. In addition, substantial equivalence is noted towards the intended use in other soft tissue systems of the human body.

The basic system is a radial cutting of a cutting cannula on a helicoidal shaped receiving element. This system can be operated manually, whereby the system is advanced by the aid of a trocar needle up to the diseased area. Combined, this needle set is called the Spirotome and can be delivered single-use or as a reusable device.

The Coramate is a powered device that operates the same needles automatically. The interface with the patient is the same both in the Coramate and Spirotome: i.e. the intenate set. In addition, the Coramate includes a vacuum to the needles for maximal performance. The Coramate contains a combination of interfaces, motors and software in addition to a battery with loader. The interfaces fix the needle set into the device. in addition to a batter, form the necessary movements of the needles. The software guides the motors into smooth and ordered movements of the needles. The batteries galled the heater Accessories may be added to the system: e.g. releasing element, spacer, protecting ring, and battery loader.

Performance data

Thorough preclinical testing was performed to ensure the device performs as intended. In particular most laboratory and preclinical testing was done on animal tissues to ensure maximum performance in the human situation.

Clinical testing indicates that all performance and safety aims are reached. Since the interface of the system is the same in the Spirotome compared to the Coramate, all the inical evidence gained by the Spirotome is relevant to the Coramate. Most of the clinical work has been done in human breast tissues as has been published in international PEER reviewed Journals and Meetings. In addition, recent clinical international + LLN relating to the performance in various other soft tissues than the breast. In summary, all this clinical data indicate that the Coramate and the brough " if our " " on as intended, with aimed performance and maximal safety and similar to the 'Indications for Use' of the predicate device. In particular, no complication was noted up to now in the clinical tests and subsequent vigilance quality control follow-up.

Control one and Coramate devices comply with the European Medical Device Directive 92/42/EEC and clearance was given for all soft tissues of the human body. All requested standard testing according to the claims made have been done.

Conclusion

Oonclusion Based upon the tooting and companser soft tissues than the breast was substantially the Oblamatoropirotomo of the predicate devices. The system performs as intended and raises no new safety or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2008

MedInvents % Mr. Jaak Janssens Klein Hillststraat 5 Hasselt, Limburg Belgium 3500

Re: K080095

Trade/Device Name: Coramate system Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 6, 2008 Received: March 17, 2008

Dear Mr. Janssens:

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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jaak Janssens

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K080095

Page 25 of 64 pages

Page 1 of 5

Coramate needle

Indications for Use

510(k) Number (if known): K080095

Device Name: Coramate system

Indications For Use:

The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.

The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.

An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient.

In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ko80095

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Spirotome needle

Indications for Use

510(k) Number (if known): K080095

Device Name: Spirotome system

Indications For Use:

The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.

The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ko 80095

Page 3 of 5

Cervicore needle

Indications for Use

510(k) Number (if known): K080095

Device Name: Cervicore Spirotome

Indications For Use:

The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix.

The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Nil RP Gln for mam

Division of General, Restorative, and Neurological Devices

K080095 510(k) Number_

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Ko80095

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Page 4 of 5

Easy Punch

Indications for Use

510(k) Number (if known): K080095

Device Name: Easy Punch Spirotome

Indications For Use:

The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin.

The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.

The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle firman

Division of General. Restorative. and Neurological Devices

510(k) Number K080095

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Page 29 of 64 pages

Kofoo 95-

Spirotome Bone

Page 5 of 5-

Indications for Use

510(k) Number (if known): K080095

Device Name: Spirotome Bone

Indications For Use:

The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures.

The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINU ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.