· The Intact® Gen2 System is indicated to provide tissue sampling of breast abnormalities.
· The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
· The Intact · Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The Intact Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. .

Device Description

The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample to preserve the tissue architecture for histologic examination. The device is a highfrequency, vacuum-assisted electrosurgical device used to remove tissue by electrosurgical cutting and simultaneous capture of an incised tissue volume. The device includes the following components:

Probe/Wand
Intact® Gen2 Probe/wand (Sizes: 12mm, 15mm, 20mm and 30mm)
Handle
Gen2 Controller with Power Cord and Foot Pedal
Table Mount
Cart

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Intact Gen2 System, which is a biopsy instrument. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria based on diagnostic performance metrics. Therefore, many of the requested details about acceptance criteria, performance metrics (like sensitivity, specificity), ground truth, and expert involvement are not available in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Verification Testing Summary Table" for comparing the proposed Intact Gen2 System with its predicate device (Intact BLES System). The acceptance criteria are generally "Pass," indicating that the device met the requirements of the specified standards. The performance is reported as "Pass" for both the proposed and predicate devices in most categories, with comments often stating "Equivalent."

Test Type	Acceptance Criteria	Reported Gen2 Performance	Reported Predicate Performance	Comments
Safety and Essential Performance	Meet requirements of IEC 60601-1, 3rd Edition and IEC 60601-2-2	Pass	Pass	Equivalent; Both systems meet requirements of IEC 60601-1, 3rd Edition and IEC 60601-2-2
EMC Tests	Meet requirements of IEC 60601-1-2	Pass	Pass	Equivalent; Both systems meet requirements of IEC 60601-1-2
Software Verification Tests	Meet requirements of IEC 62304	Pass	Not applicable	Proposed software meets requirements of IEC 62304. Predicate contains no software, utilized hardware for all functions.
Usability Tests	Meet requirements of EN 60601-1-6	Pass	Pass	Equivalent; Both systems meet the requirements of EN 60601-1-6.
Bench Performance Verification Test	Does not deliver more total energy to the biopsy tissue sample than the predicate.	Pass	Pass	Equivalent; Demonstrated that the proposed system does not deliver more total energy to the biopsy tissue sample than the predicate.
Thermal Artifact Verification Testing	Thermal artifacts in biopsy tissue samples are equivalent to the predicate.	Pass	Pass	Equivalent; Demonstrated that the thermal artifacts in biopsy tissue samples are equivalent.
Note: The specific quantitative acceptance criteria for "not delivering more total energy" or "equivalent thermal artifacts" are not detailed in this summary.

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

The document mentions "extensive bench and animal testing" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided. The testing appears to be primarily laboratory-based (bench and animal testing).

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

This information is not available in the provided text. Since the study focuses on engineering and performance characteristics (like energy delivery and thermal artifacts) using bench and animal models, the concept of "ground truth" established by clinical experts (like radiologists) for diagnostic performance is not applicable in the context described.

4. Adjudication Method for the Test Set

This information is not available. Given the nature of the testing described (bench and animal studies for electrosurgical properties), an adjudication method in the context of clinical interpretation by multiple readers is not relevant.

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

There is no mention of an MRMC comparative effectiveness study in this document. The device is a biopsy instrument, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an electrosurgical biopsy instrument, not an algorithm, and it requires human operation.

7. The Type of Ground Truth Used

For the "Bench Performance Verification Test" and "Thermal Artifact Verification Testing," the ground truth implicitly refers to:

Measurement of energy delivered to biopsy tissue samples.
Assessment of thermal artifacts in biopsy tissue samples.
These are objective, measurable physical properties, likely evaluated using standard laboratory techniques and instruments, rather than clinical ground truth like pathology or outcomes data. The document states the goal was to demonstrate equivalence to the predicate device in these aspects.

8. The Sample Size for the Training Set

This is not applicable. The device is a biopsy instrument and does not involve AI or machine learning models that require a "training set."

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

This is not applicable for the reasons stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 15, 2016

Intact Medical Corporation % Dr. John Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 22204

Re: K152596

Trade/Device Name: Intact® Gen2 System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: January 19, 2016 Received: January 19, 2016

Dear Dr. Smith:

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. 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 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 devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)
K152596

Intact® Gen2 System Device Name:

Indications for Use (Describe)

· The Intact® Gen2 System is indicated to provide tissue sampling of breast abnormalities.
· The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
· The Intact · Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
The Intact Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. .

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or 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.

In instances when a patient presents with a palpable abnormality that has benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact Gen2 System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue marqins 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

Intact® Gen2 System
Applicant	Intact Medical, Inc.
Establishment Registration Number	1226766
Contact Person	John VachaIntact Medical Corporation550 Cochituate Road - Suite 25East Wing, Floor 4Framingham, MA 01701Phone: 508-655-7820Fax: 508-655-7822
Summary Date	February 12, 2016
Proprietary Name	Intact® Gen2 System
Classification	Class II
Classification Name	Biopsy Instrument and Electrosurgical Cutting &Coagulation Device & Accessories
Regulation Number	21 C.F.R. § 876.1075
Classification	Product Code KNW
Predicate Device	Intact® BLES with Intact® Excision XL wand andhandle (K142477)

Device Description

1. Probe/Wand

Intact® Gen2 Probe/wand (Sizes: 12mm, 15mm, 20mm and 30mm)

1. Handle
1. Gen2 Controller with Power Cord and Foot Pedal
1. Table Mount

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Available to fit stereotactic tables (Fischer and Lorad mounts).

5. Cart

Probe/Wand:

The probes/wands are sterile and intended for single use. They utilize a sharp blade to access the target lesion.

The Cut/Capture Electrode is located at the distal end of the wand. It consists of five (5) small diameter wire electrodes that cut tissue with a mono-polar electrosurgical cutting current and purse down to close the distal end of the cutting/capture element to make a circumscribing incision and capture of the target tissue.

The wand contains a resistor of unique value for each wand size (12mm, 15mm, 20mm, or 30mm) that is used by the Controller to identify the specific wand size installed in the handle.

Handle:

The handles consist of a hand piece at the distal end of a cable that mates with the Probe/Wand, and a connector at the proximal end of a cable that mates with the Controller. The handle is either mated to a stereotactic table using a mount or handheld for ultrasound-guided procedures.

Controller:

The Intact Gen2 Controller consists of a radiofrequency generator, which operates at a single, preset frequency. The Intact Gen2 Controller is designed to apply a high-frequency voltage during the biopsy specimen capture phase (involving Capture Electrodes). The power applied for each wand size is optimized to (1) be sufficiently high to form the electrical arc essential to effect the highly localized vaporization of cellular fluid which, thereby, enables electrosurgical cutting and (2) be sufficiently low to minimize the depth of necrosis induced in the biopsy specimen and the surrounding tissue. The controller incorporates a microprocessor and software.

Power Cord:

The Intact® Controller Power Cord is a standard detachable power cord that connects the Controller to the line voltage output receptacle.

Foot Pedal:

The foot pedal assembly is a floor-mounted, two-pedal device, which attaches to the rear of the Intact" Gen2 Controller. The two pedals provide the Arm and Capture functions, analogous to those buttons on the handle. Either the footswitch or the handle controls can be used interchangeably.

Cradle:

Multiple versions of the cradle are available to fit commercially available stereo-tactic tables. .

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Cart:

This is an off-the-shelf moveable cart that houses the components of the system.

Required for the procedure but not included in the system are: An off-the-shelf vacuum unit and a patient return electrode.

Intended Use/Indications for Use

· The Intact · Gen2 System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
· The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
· The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
· The Intact® Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12-30mm.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact" Gen2 System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. 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.

Technical and Operational Characteristics

The Intact Gen2 System works on the same principle of operation as the predicate device. Both require setting up a high-frequency voltage between an electrosurgical electrode (i.e., active electrode) and the tissue to be incised. This voltage creates an arc between the electrode and the tissue. This arc, by virtue of the high temperature, induced at the point of impingement with tissue, vaporizes the tissue in its vicinity.

This 510(k) notice implements technological modifications to the wands (addition of a resistor) and controller (addition of a microprocessor and software) to individualize the amount of power required to capture a sample based on probe size. Thus, less power is required to capture a tissue sample

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for each sized probe. The proposed device is capable of performing to its intended use similar to the predicate device.

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Summary of Testing

Verification Testing Summary Table
Test Type	ProposedIntact® Gen2System	PredicateIntact® BLESSystem IntactBLES(K142477)	Comments
Safety andEssentialPerformance Tests	Pass	Pass	EquivalentBoth systems meet requirements of IEC60601-1, 3rd Editionand IEC 60601-2-2
EMC Tests	Pass	Pass	EquivalentBoth systems meet requirements of IEC60601-1-2
SoftwareVerification Tests	Pass	Not applicable	Proposed software meets requirements ofIEC 62304.Predicate contains no software, utilizedhardware for all functions.
Usability Tests	Pass	Pass	EquivalentBoth systems meet the requirements ofEN 60601-1-6.
Bench PerformanceVerification Test	Pass	Pass	EquivalentDemonstrated that the proposed systemdoes not deliver more total energy to thebiopsy tissue sample than the predicate.
Thermal ArtifactVerification Testing	Pass	Pass	EquivalentDemonstrated that the thermal artifacts inbiopsy tissue samples are equivalent

Rationale for Substantial Equivalence

The proposed modifications reduce the power introduced to the patient to capture a similar intact sample (size, shape, weight, architectural integrity, thermal artifact) as that of the predicate device. The proposed device is capable of performing to its intended use similar to the predicate device.

The Intended Use/Indications for Use statement and technological characteristics of the Intact Gen2 System device and the predicate devices were compared. The Intended Use/Indications for Use statements of the devices are identical. The proposed changes to the technology are supported by extensive bench and animal testing described above and are similar to that of the predicate device with the same intended use.

Conclusion

Based on similar technology and operation characteristics as well as the bench and animal performance testing, the Intact Gen2 System device is substantially equivalent to the 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.