MANOA BREAST BIOPSY SYSTEM

K033205 · Manoa Medical, Inc. · GEI · Feb 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033205
• Device Name: MANOA BREAST BIOPSY SYSTEM
• Applicant: Manoa Medical, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.

Device Story

Manoa Breast Biopsy System is a minimally invasive device for diagnostic breast tissue sampling. System components include a sheath introducer, tissue cutter, specimen retriever, and electrosurgical cable. Device penetrates, cuts, and collects intact tissue specimens during biopsy procedures. Operated by clinicians in a clinical setting. Output is an intact tissue specimen for diagnostic evaluation. Benefit is minimally invasive acquisition of tissue for diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components: sheath introducer, tissue cutter, specimen retriever, electrosurgical cable. Materials are ISO 10993-1 compliant. Operates via electrosurgical cutting and coagulation (21 CFR 878.4400).

Indications for Use

Indicated for diagnostic sampling of breast tissue in patients undergoing breast biopsy procedures. Not for therapeutic use.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Rubicor Medical, Inc.: EnCapsule
• Ethicon-Endosurgery: Mammotome Hand-Held
• SenoRx: Easy Guide
• Valleylab: Coated Electrodes
• Imagyn: SiteSelect

Submission Summary (Full Text)

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K033205

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## 510(k) Summary of Safety and Effectiveness F.

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

| SUBMITTER: | Manoa Medical, Inc.<br>1017 El Camino #361<br>Redwood City, CA 94063<br>Phone: [phone]<br>Fax: [phone] | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| CONTACT PERSON: | Niyazi Beyhan | |
| DATE PREPARED: | September 30, 2003 | |
| CLASSIFICATION NAME: | Electrosurgical Cutting and Coagulation Device<br>and Accessories (21 CFR 870.4400) | |
| COMMON NAME: | Breast biopsy device | |
| PROPRIETARY NAME: | Not Yet Determined | |
| PREDICATE DEVICES: | Rubicor Medical, Inc.: EnCapsule<br>Ethicon-Endosurgery: Mammotome Hand-Held<br>SenoRx: Easy Guide<br>Valleylab: Coated Electrodes<br>Imagyn: SiteSelect | |
| DEVICE DESCRIPTION: | The Manoa Breast Biopsy System is comprised<br>of a sheath introducer, a tissue cutter, a<br>specimen retriever and an electrosurgical cable.<br>The Manoa Breast Biopsy System is a<br>minimally invasive biopsy device designed to<br>penetrate, cut and collect an intact tissue<br>specimen during a biopsy procedure. | |
| INDICATIONS FOR USE: | The Manoa Breast Biopsy System is intended<br>for diagnostic sampling of breast tissue during a<br>breast biopsy procedure. It is for diagnostic<br>purposes only and is not intended for<br>therapeutic use. | |
| MATERIALS: | The Manoa Breast Biopsy System is composed<br>of biosafe materials which are ISO 10993-1<br>compliant for their intended patient contact<br>profile. | |
| 510(k) Premarket Notification | Manoa Medical, Inc. | Page 13 |

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Manoa Medical, Inc.

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Image /page/1/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized representation of a human figure with three heads, symbolizing health, human services, and the public. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Roberta Lee, M.D. Founder & CLO Manoa Medical, Inc. 1017 El Camino PMB 361 Redwood City, California 94063

Re: K033205

Trade/Device Name: Manoa Breast Biopsy System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 29, 2003 Received: January 2, 2004

Dear Dr. Lee:

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. Iisting 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 - Roberta Lee, M.D.

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 [phone]. Also, please note the regulation entitled, "Mishranding 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Melleman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K033205

Name: Manoa Breast Biopsy System

Indications for Use:

Indications for Use

E.

The Manoa Breast Biopsy System is intended for diagnostic sampling of breast tissue during a breast biopsy procedure. It is for diagnostic purposes only and is not intended for therapeutic use.

Prescription Use: X (Per 21 CFR 801.109)

OR

Over-The-Counter Use:

K033205

(Please do not write below this line - continue on another page if needed.)

'DRH, Office of Device Evaluation (ODE) 11/2

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

**510(k) Number** K033305

(Division Sign-Off) Division of General Restorative Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

510(k) Premarket Notification

Manoa Medical, Inc.

Page 12

PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Manoa Medical, Inc.