Intact Advance and Intact Excision XL, Intact BLES

• K Number: K142477
• Device Name: Intact Advance and Intact Excision XL, Intact BLES
• Manufacturer: INTACT MEDICAL CORPORATION
• Date Cleared: 2014-12-15 ( 103 days)
• Product Code: KNW
• Regulation Number: 876.1075

Intended Use

- The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue sampling of breast abnormalities - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to histologic examination with partial removal of a palpable abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm - The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm

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 high frequency, vacuumassisted electrosurgical devices used to remove tissue by electro-surgical cutting and simultaneous capture of an incised tissue volume. The devices include the following components: 1. Probe/Wand (1a) Intact BLES Probe/wand (1b) Intact Advance BLES Probe/wand (1c) Intact Excise XL Probe/wand 2. Handle (2) The Intact BLES Handle (2a) Intact Excise XL Handle 3. Intact Medical ™ Model 3000 Controller 4. Controller Power Cord Footpedal 5. Table Mount (6a) Table Mount, BLES attaches the Intact BLES Handle to a stereotactic table (Fischer and Lorad mounts). (6b) Table Mount, Excise XL attaches the Intact Excise XL Handle to a stereotactic table (Fischer and Lorad mounts). 6. Vacuum Source 7. Cart

Predicate Devices

K081057,K060413

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and electrosurgical aspects of tissue sampling, with no mention of AI or ML for analysis, image processing, or decision support.

Therapeutic

No

The device is described as a biopsy tool intended for tissue sampling and removal for histologic examination, primarily for diagnostic purposes rather than direct treatment or therapy.

Diagnostic

Yes

The device is indicated to provide tissue samples for diagnostic sampling of breast abnormalities and for histologic examination, which are processes involved in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly lists multiple hardware components including probes, handles, a controller, power cord, footpedal, table mounts, vacuum source, and a cart.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) to obtain the tissue sample.
• The intended use and device description clearly state that the device is a biopsy tool used to sample breast tissue. The tissue is then intended for histologic examination, which is the laboratory process performed after the tissue is obtained by this device.
• The device's function is to physically remove tissue using electrosurgical cutting and vacuum assistance. It does not perform any analysis or testing on the tissue itself.

Therefore, the Intact® BLES with Intact® Excision XL wand and handle is a surgical/biopsy device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

• The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue sampling of breast abnormalities.
• The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality.
• The Intact® BLES with Intact® Excision XL wand and handle is intended to histologic examination with partial removal of a palpable abnormality.
• The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm

The extent of a histologic abormality cannot always be readly determined from palpation or imaged appearance. Therefore of removal of the palpable or imaged evidence of an abnormality does not premoval of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essettial that the tissue margins be examined for completeness of removal usings standard surgical procedures.

In instances when a patient presents with a palpable absornality that has been classified as benign through criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact® Excision XL wand and handle 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.

Product codes

KNW

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 high frequency, vacuumassisted electrosurgical devices used to remove tissue by electro-surgical cutting and simultaneous capture of an incised tissue volume. The devices include the following components:

1. Probe/Wand
   (1a) Intact BLES Probe/wand
   (1b) Intact Advance BLES Probe/wand
   (1c) Intact Excise XL Probe/wand
2. Handle
   (2) The Intact BLES Handle
   (2a) Intact Excise XL Handle
3. Intact Medical ™ Model 3000 Controller
4. Controller Power Cord Footpedal
5. Table Mount
   (6a) Table Mount, BLES attaches the Intact BLES Handle to a stereotactic table (Fischer and Lorad mounts).
   (6b) Table Mount, Excise XL attaches the Intact Excise XL Handle to a stereotactic table (Fischer and Lorad mounts).
6. Vacuum Source
7. 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 electro-surgical 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.

Handle:
The handles consist of a hand piece at the distal end of a cable that mates with the Probe/Wand, a connector at the proximal end of a cable that mates with the Controller, a grip provided for ultrasound hand held procedures. The grip is replaced with a cradle for stereotactically guided procedures.

Controller:
Intact Medical Model 3000 Controller consists of a radiofrequency generator, which operates at a single, preset frequency to apply a high-frequency voltage during the biopsy specimen capture phase.

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, three-pedal device, which attaches to the Intact Model 3000 Controller. The three pedals provide probe and handle controls to allow the user an alternate interface (to the handle buttons).

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

Vacuum Source:
An off the shelf unit that allows for suction and removal of fluids during the procedure

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Intact® BLES with Intact® Excision XL wand and handle was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, animal testing, clinical testing, biocompatibility and sterilization testing. Since there is no change to the technology of the Intact® BLES with Intact® Excision XL wand and handle and the only proposed change is limited to the Indications for Use, no additional bench or animal testing was conducted to support demonstration of substantial equivalence in performance from the Intact® Excision XL wand and handle to its predicate device.

However, additional clinical data was generated to support the proposed additional indications for use claim. Complete Excision Rates were evaluated as a surrogate measure to assess the ability to remove sufficient, undisrupted tissue to preserve tissue architecture and to permit a definitive diagnosis.

A tabular summary of representative medical literature documenting the use of the Intact® BLES with Intact® Excision XL wand and handle as a tool in the field of breast biopsy was provided.
Patient Quantity: 224 (Total for BLES studies)
Complete Excision Rate: 76% (Total for BLES studies)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Complete Excision Rate: 76%

Predicate Device(s)

K081057, K060413

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single image. The profiles are arranged in a way that suggests movement or progress.

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

December 15, 2014

Intact Medical Incorporated % Dr. John J. Smith Hogan Lovells US LLP 555 Thirteenth Street, North West Washington, District of Columbia 20004

Re: K142477

Trade/Device Name: Intact® BLES with Intact® Excision XL wand and handle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: November 21, 2014 Received: November 21, 2014

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 (reporting of medical

1

device-related 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

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

for

Sincerely yours,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known) K142477

Intact® BLES with Intact® Excision XL wand and handle Device Name:

Indications for Use (Describe)

• The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue sampling of breast . abnormalities
• . The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality
• The Intact® BLES with Intact® Excision XL wand and handle is intended to histologic examination with partial removal of a palpable abnormality
• . The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm

The extent of a histologic abormality cannot always be readly determined from palpation or imaged appearance. Therefore of removal of the palpable or imaged evidence of an abnormality does not premoval of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essettial that the tissue margins be examined for completeness of removal usings standard surgical procedures.

In instances when a patient presents with a palpable absornality that has been classified as benign through criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact® Excision XL wand and handle 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Intact® BLES with Intact® Excision XL wand and handle

| Applicant | Intact Medical Corporation
550 Cochituate Road - Suite 25
Framingham, MA 01701
Phone: [phone]
Fax: [phone] | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment Registration Number | 1226766 | |
| Contact Person | John J. Smith, M.D., J.D.
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington, DC 20004
Phone: [phone]
Fax: [phone] | |
| Summary Date | December 15, 2014 | |
| Proprietary Name | Intact® BLES with Intact® Excision XL wand and handle | |
| 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 Devices | 10mm, 12mm, 15mm and 20mm Intact® BLES
(K060413) manufactured by Intact Medical Corporation
Intact® Advance and Intact Excision XL (K081057
"Primary Predicate") manufactured by Intact Medical | |

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 high frequency, vacuumassisted electrosurgical devices used to remove tissue by electro-surgical cutting and simultaneous capture of an incised tissue volume. The devices include the following components:

1. Probe/Wand

• (1a) Intact BLES Probe/wand
• (1b) Intact Advance BLES Probe/wand
• (1c) Intact Excise XL Probe/wand

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2. Handle

(2) The Intact BLES Handle

• (2a) Intact Excise XL Handle
• 3. Intact Medical ™ Model 3000 Controller
• 4. Controller Power Cord Footpedal
• 5. Table Mount
  • (6a) Table Mount, BLES attaches the Intact BLES Handle to a stereotactic table (Fischer and Lorad mounts).
  • (6b) Table Mount, Excise XL attaches the Intact Excise XL Handle to a stereotactic table (Fischer and Lorad mounts).
• 6. Vacuum Source
• 7. 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 electro-surgical 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.

Handle:

The handles consist of a hand piece at the distal end of a cable that mates with the Probe/Wand, a connector at the proximal end of a cable that mates with the Controller, a grip provided for ultrasound hand held procedures. The grip is replaced with a cradle for stereotactically guided procedures.

Controller:

Intact Medical Model 3000 Controller consists of a radiofrequency generator, which operates at a single, preset frequency to apply a high-frequency voltage during the biopsy specimen capture phase.

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, three-pedal device, which attaches to the Intact Model 3000 Controller. The three pedals provide probe and handle controls to allow the user an alternate interface (to the handle buttons).

Cradle:

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

Vacuum Source:

An off the shelf unit that allows for suction and removal of fluids during the procedure

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Intended Use/Indications for Use

• . The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities
• . The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality
• The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality
• . The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm

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 been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact BLES with Intact® Excision XL wand and handle 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 proposed 510k is limited to a change in label claims. No changes have been made to the device. The Intact® BLES with Intact® Excision XL wand and handle is identical in design, operational and technological characteristics as the predicate devices (K060413; K081057) and supports that no new safety concerns are being raised by change in intended use/indications for use statement and thus raises no new issues of safety or effectiveness. ).

Summary of Testing

The Intact® BLES with Intact® Excision XL wand and handle was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, animal testing, clinical testing, biocompatibility and sterilization testing. Since there is no change to the technology of the Intact® BLES with Intact® Excision XL wand and handle and the only proposed change is limited to the Indications for Use, no additional bench or animal testing was conducted to support demonstration of substantial equivalence in performance from the Intact® Excision XL wand and handle to its predicate device.

However, additional clinical data was generated to support the proposed additional indications for use claim. Complete Excision Rates were evaluated as a surrogate measure to assess the ability to remove sufficient, undisrupted tissue to preserve tissue architecture and to permit a definitive diagnosis.

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Provided in the table below is a tabular summary of representative medical literature documenting the use of the Intact® BLES with Intact® Excision XL wand and handle as a tool in the field of breast biopsy.

| Citation | Author | Patient Quantity | Complete Excision Rate
(%) |
|----------|-------------------------------------------------------------------------------------------|------------------|-------------------------------|
| 1 | Whitworth, P | 25 | 88 |
| 2 | Whitworth, P,
Simpson, Poller,
Schonholz, Turner,
Phillips, Johnson,
McEachin | 10 | 100 |
| 3 | Naglaa Abdel Razek | 76 | 76 |
| 4 | Schonholz, S | 37 | 49 |
| 5 | Steven D. Allen ,
Ashish Nerurkar ,
Guidabaldo U. Querci
Della Rovere | 76 | 83 |
| TOTAL | BLES | 224 | 76% |

Tabular summary of medical literature with Intact® Excision XL wand and handle

Citation number:

• 1. Whitworth, P. Percutaneous Stereotactic Lumpectomy and Partial Breast Irradiation for Small Breast Cancers: Reducing Overtreatment Presented at: Miami Breast Meeting 2014 -Publication pending
• 2. Whitworth, Simpson, Poller, Schonholz, Turner, Phillips, Johnson, McEachin: Definitive Diagnosis for High-Risk Breast Lesions Without Open Surgical Excision: The Intact Percutaneous Excision Trial (IPET), Annals of Surgical Oncology (2011) 18:3047-3052
• Naglaa Abdel Razek. Percutaneous breast lesion system (BLES): a new tool for 3. complete closed excision of high risk lesions. European Congress of Radiology 2013.
• Schonholz, S. Complete Excision and Reexcision Rates Following Percutaneous biopsy using 4. the Intact Breast Lesion Excision System and the Mammotome. ASBS 2013 in publication for review with Journal of Surgical Oncology.
• 5. Steven D. Allen & Ashish Nerurkar &Guidabaldo U. Querci Della Rovere The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? European Radiology 2011.

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Rationale For Substantial Equivalence

The Intended Use/Indications for Use statement and technological characteristics of the Intact® BLES with Intact® Excision XL wand and handle and the predicate devices were compared. The Intended Use/Indications for Use statement of the devices have the same general claims and do not raise new questions of safety and performance. Both the predicate device and proposed 510k device an intact sample of tissue for histological assessment. This proposed change to the Indications for Use is well supported by a review of the peer reviewed clinical literature and society presentations and are similar to that of the predicate devices with the same general intended use.

Conclusion

Based on the similar label, identical technology and operation characteristics as well as the clinical performance testing, the Intact® BLES with Intact® Excision XL wand and handle device is substantially equivalent to the predicate devices.