The Coramate/Spirotome system is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Coramate/Spirotome system is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surqical procedures.

Device Description

The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body, in particular from the female breast to detect and confirm malignant cells in the earliest phase of progression.

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. The trocar needle brings the cutting cannula up to the diseased site. The receiving needle, with a helix at the top, penetrates the diseased area, and the cutting cannula frees the sample from the surrounding tissues.

The following accessories are optionally provided with the system e.g. releasing element, needle spacer and needle protecting tube.

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. The 4 small motors perform the necessary movements of the needles. The software guides the motors into smooth and ordered movements of the needles. The batteries power the device.

AI/ML Overview

The provided text describes a medical device called the Coramate/Spirotome system, a mechanical biopsy device intended for diagnostic sampling of breast tissue. However, it does not contain a detailed study with specific acceptance criteria and performance data in the format requested.

The document is a Premarket Notification 510(k) Summary for regulatory purposes. It focuses on demonstrating substantial equivalence to a predicate device (Mammotome Biopsy System, K033700) rather than providing a detailed clinical study with quantitative performance metrics against pre-defined acceptance criteria.

Here's a breakdown of the information that can be extracted and what is missing based on your request:

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

Missing from the text. The document states, "Clinical testing indicates that all performance and safety aims are reached" and that the device performs "with aimed performance and maximal safety and similar to the predicate device." However, no specific numerical acceptance criteria (e.g., minimum diagnostic accuracy, sample yield, complication rates) or quantitative performance results are provided to populate such a table.

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

Sample Size: Not explicitly stated. The text mentions "Most of the clinical work has been done in human breast tissues." No specific number of patients or samples is given for a test set.
Data Provenance: The document mentions "European Medical Device Directive 92/42/EEC" and the manufacturer's location in Belgium, implying European data. The "international PEER reviewed Journals and Meetings" suggest a broader geographic scope, but specific countries are not detailed.
Retrospective or Prospective: Not explicitly stated for either the Spirotome or Coramate clinical work.

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)

Missing from the text. There is no information about the number or qualifications of experts used for establishing ground truth. The text mentions "histologic examination" as the method for confirming the nature of the samples, implying pathologists were involved, but specifics are absent.

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

Missing from the text. There is no description of any adjudication method for ground truth establishment.

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. The Coramate/Spirotome system is a mechanical biopsy device, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images with or without AI assistance. Therefore, an MRMC study as described is not relevant to this device.

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

Not applicable. As a mechanical biopsy device, the concept of "algorithm only" or "standalone" performance without human intervention (for taking the biopsy) doesn't apply directly in the way it would for an AI diagnostic algorithm. The device's performance is inherently linked to its use by a human operator.

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

The ground truth mentioned is histologic examination of the tissue samples. This implies a pathology-based ground truth.

8. The sample size for the training set

Missing from the text. There is no mention of a "training set" in the context of device development or evaluation described here. The clinical work is referenced, but not in terms of training a distinct model. The preclinical testing on animal breast tissues could be considered an early phase of "training" or optimization, but no sample size is given.

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

Missing from the text. As no specific training set is identified, there is no description of how its ground truth was established.

In summary, the provided 510(k) summary focuses on regulatory approval through substantial equivalence, and therefore lacks the detailed clinical study information and quantitative performance metrics that would be found in a research paper directly describing acceptance criteria and their fulfillment.

Summary

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Premarket Notification 510(k) Summary

(per 21 CFR 807.92)

Coramate/Spirotome System

1. Submitted by:

Magda Buttiens CEO Medinvents B-3500 Hasselt - Belgium

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

Date prepared: April 4, 2006

2. Device Name:

Trade Name: Coramate/Spirotome system Classification Name: Biopsy Needle

3. Predicate Device:

The Mammotome Biopsy System (K033700) is substantially equivalent to other biopsy needle systems on the market, including the Coramate/Spirotome system.

4. Device Description:

The following accessories are optionally provided with the system e.g. releasing element, needle spacer and needle protecting tube.

5. Intended Use

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6. Technological Characteristics

The Coramate/Spirotome system is equivalent to the currently marketed vacuum assisted powered macrobiopsy systems, including the Mammotome (K033700). It contains a needle set and a hand held powered device. In addition, it has the same intended use.

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. 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 needle set. In addition, the Coramate includes a vacuum to the needles for maximal performance.

Accessories may be added to the system: e.g. releasing element, spacer, protecting ring, and battery loader.

The technological differences between the Coramate/Spirotome and the predicate device were introduced to improve performance and safety.

7. 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 breast 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 clinical 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 evidence is added relating only to the Coramate. In summary, all this clinical data indicate that the Coramate and Spirotome perform as intended, with aimed performance and maximal safety and similar to the predicate device. In particular, no complication was noted up to now in the clinical tests and subsequent vigilance quality control followup.

The Spirotome device complies with the European Medical Device Directive 92/42/EEC. The Coramate device is submitted for approval in the European Community and

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approval is pending. All requested standard testing according to the claims made have been done.

8. Conclusion

Based upon the testing and comparison to the predicate device, the Coramate/Spirotome system has the same intended use with similar technological characteristics as 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 Department of Health and Human Services (HHS) in the United States. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDINVENTS % Magda Buttiens CEO Klein Hillststraat 5 Hasselt, Limburg Belgium 3500

JUL 1 3 2006

Re: K060384

Trade/Device Name: Coramate/Spirotome System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 19, 2006 Received: July 6, 2006

Dear Ms. Buttiens:

This letter corrects our substantially equivalent letter of May 10, 2006.

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 cnclosure) 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

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Page 2 - Ms. Magda Buttiens

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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

fartare Briend

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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Indications for Use

510(k) Number (if known): K 060384

Device Name: Coramate/Spirotome system

Indications For Use:

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) LON IN

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

510(k) Number K060384

Page 1 of 1_

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.