SURECORE BIOPSY DEVICE

K102756 · Chest Innovations, Inc. · KNW · Nov 29, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K102756
• Device Name: SURECORE BIOPSY DEVICE
• Applicant: Chest Innovations, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Nov 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of 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 surgical procedures.

Device Story

SureCore™ Biopsy Device is a sterile, single-use electrosurgical instrument for breast tissue biopsy. Device utilizes monopolar radiofrequency (RF) energy (510 kHz sinusoidal wave, max 65 Watts) to cut tissue during open surgical or endoscopic procedures. Input is tissue targeted by clinician; output is cylindrical, full-core tissue specimen (2.4 mm diameter). Device is operated by physicians in clinical settings. RF energy is delivered via external generator (e.g., Valley Lab Force II). Clinician uses specimen for histologic examination to assess breast abnormalities. Benefit includes ability to obtain diagnostic tissue samples for pathology.

Clinical Evidence

No clinical data. Performance validated via non-clinical bench testing including tensile strength, in-vitro performance, electrical safety, electromagnetic compatibility, sterility, shelf life, biocompatibility, and in-vivo animal performance.

Technological Characteristics

Electrosurgical biopsy instrument; monopolar RF energy (510 kHz, max 65W); 10.5G profile, 24 cm length; 2.4 mm diameter cylindrical specimen; powered by external 120V RF generator; sterile, single-use.

Indications for Use

Indicated for patients requiring diagnostic breast tissue sampling for histologic examination of breast abnormalities, including partial or complete removal of imaged abnormalities.

Regulatory Classification

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.

Predicate Devices

• Neothermia Corporation en-bloc® Biopsy System (K050737)
• Angiotech BioPince™ Ultra Full Core Biopsy Instrument (K101832)

Submission Summary (Full Text)

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## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### A. Name, Address, Phone and Fax Number of Applicant

Chest Innovations, Inc. 827 Canoas Creek Circle San Jose, CA 95136 Phone: [phone] Fax: [phone]

#### B. Contact Person

Salmaan Hameed Chief Executive Officer Phone: [phone] [e-mail]

Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant [phone] [e-mail]

#### C. Date Prepared

November 28, 2011

#### D. Device Name

| Trade Name: | SureCore™ Biopsy Device | | |
|----------------------|------------------------------------------------------------------|--|--|
| Common Name: | Biopsy Instrument | | |
| Classification Name: | Biopsy Instrument (21 CFR§ 876.1075, Product Code<br>KNW)<br>and | | |
| | Electrosurgical, Cutting & Coagulation & Accessories | | |
| | (21 CFR§878.4400, Product Code GEI) | | |

#### E. Predicate Devices

The SureCore™ Biopsy Device is substantially equivalent to:

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- Neothermia Corporation en-bloc® Biopsy System K050737 cleared March 31. O 2005
- o Angiotech BioPince™ Ultra Full Core Biopsy Instrument K101832 cleared August 27, 2010

#### ட் Device Description

The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.

#### G. Intended Use

The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of 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 surgical procedures.

| Manufacturer | Chest Innovations | Neothermia Corporation | Angiotech |
|---------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SureCore™ Biopsy Device | en-bloc ®Biopsy | BioPince™ Ultra Full Core Biopsy Instrument |
| 510(k) Number | K102756 | K050737 | K101832 |
| Intended Use | provide tissue samples for diagnostic sampling of breast abnormalities. | provide tissue samples for diagnostic sampling of breast abnormalities. | multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions. |
| Product Code | KNW; GEI | GEI | KNW |
| Mechanism of Action | radiofrequency energy to cut the tissue during open surgical or endoscopic procedures | radiofrequency energy to cut the tissue during open surgical or image guided procedures | mechanical cutter to cut the tissue during percutaneous, open surgical or endoscopic procedures |

#### H. Technological Comparison

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| Sample Size | | |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cylindrical, full core<br>specimen | Cylindrical, full core<br>specimen | Cylindrical, full core<br>specimen |
| 2.4 mm Diameter x 10-20<br>mm | 10mm wand: 12mm x13mm<br>12mm wand 13mm x 17mm<br>15mm wand: 14mm x 18mm<br>20mm wand:18 mm x 18 mm | 1.3mm-1.6mm Diameter.<br>The 13mm stroke length<br>yields a specimen of 9mm<br>length, the 23mm stroke<br>length yields a specimen of<br>19mm length, and the<br>33mm yields a specimen of<br>29mm length. |
| Average Tissue<br>Volume | | |
| 37.9 mm3 (2.4mm with<br>10mm stroke length) | 1470.9mm3 (10mm wand)'<br>2257.4mm3 (12 mm wand)<br>2772.0mm3 (15 mm wand)<br>4582.3mm3 (20 mm wand) | 16.5 mm3 (1.6mm diameter<br>device with 13mm stroke<br>length) |
| Profile | | |
| 10.5G 24 cm long | 5.3 mm Shaft Diameter<br>11.6 cm long | 14G, 16G, 18G and 20G<br>needle sizes 10cm, 15cm<br>and 20cm lengths |
| Energy Type | | |
| RF Valley Lab Force II<br>Generator | Proprietary Generator,<br>NeoThermia™ Model 3000 | Mechanical, spring<br>mechanism for firing of<br>needle. |
| Power | | |
| Standard 120 V | Standard 120 V | N/A |
| Electrical Energy<br>Delivered | | |
| Monopolar Radio Frequency<br>510 kHz Sinusoidal wave,<br>Max 65 Watts | Monopolar Radio Frequency<br>350 kHz Sinusoidal wave,<br>Max 250 watts | N/A |

#### l. Summary of Non-Clinical Data

SureCore™ Biopsy Device performance characteristics were evaluated in the following nonclinical studies: device tensile strength, in-vitro device performance, electrical safety, electromagnetic compatibility, electrical safety for endoscopic equipment, sterility testing, shelf life testing, biocompatibility and in-vivo animal device performance.

Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the SureCore™ Biopsy Device meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the SureCore™ Biopsy Device is substantially equivalent to the named predicates.

#### J. Summary of Data

The SureCore™ Biopsy Device has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the SureCore™ Biopsy Device performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the SureCore™ Biopsy Device is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.

¹ Intact™Specimen Capture Volumes@2005 Intact Medical Corporation. ML082, Rev. 0

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

NOV 2 9 2011

Chest Innovations, Inc. % Mr. Salmaan Hameed Chief Executive Officer 827 Canoas Creek Circle San Jose, California 95136

Re: K102756

Trade/Device Name: SureCore™ Biopsy Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, KNW Dated: November 11, 2011 Received: November 14, 2011

Dear Mr. Hameed:

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

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Page 2 - Mr. Salmaan Hameed

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours. Mark N. Melke rson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K102756

Device Name: Chest Innovations, Inc. SureCore™ Biopsy Device

### INDICATIONS FOR USE

The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of 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 surgical procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel R.F. Ogle for mxm
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number k102756