MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)

K013901 · Cardiofocus, Inc. · GEX · Dec 20, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013901
• Device Name: MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
• Applicant: Cardiofocus, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988)

Device Story

The Malleable Surgical Lightstic™ 180 is a laser tissue coagulator accessory used for soft tissue coagulation. It functions as a fiber optic delivery system for laser energy, allowing for both contact and non-contact modes during open or closed surgical procedures. The device is designed to be used with or without endoscopic equipment, such as laparoscopes or bronchoscopes. It is operated by surgeons in clinical settings to achieve hemostasis or tissue coagulation. The device's malleability allows for improved access to target tissues. By providing precise energy delivery, it assists the surgeon in managing tissue during cardiac and other soft tissue surgeries, potentially reducing blood loss and improving procedural efficiency.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber optic laser delivery accessory; malleable form factor; compatible with endoscopic equipment; contact or non-contact operation modes. No specific materials or software algorithms described.

Indications for Use

Indicated for the coagulation of cardiac tissue in patients undergoing surgical procedures.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Surgical Lightstic 180 (K011988)

Submission Summary (Full Text)

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DEC 2 0 2001

# 510(k) Summary

# Malleable Surgical Lightstic™ 180

K1013001

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR §807 for the Malleable Surgical Lightstic™ 180.

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Joseph Curtis | |
|------------------|----------------|
| 10 Commerce Way | |
| Norton, MA 02766 | |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | same |
| Date Prepared: | June 22, 2001 |

## Name of Device and Name/Address of Sponsor

Surgical Lightstic™ 180 CardioFocus, Inc. 10 Commerce Way Norton, MA 02766

### Common or Usual Name

Laser Tissue Coagulator

### Classification Name

Surgical Laser Instrument Accessories

## Predicate Devices

The Malleable Surgical Lightstic 180 for use in cardiac tissue is identical to the current Surgical Lightstic 180 (K011988), and substantially equivalent for indications for use in cardiac tissue.

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#### Intended Use

The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988)

### Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the CardioFocus Malleable Surgical Lightstic " 180 and the CardioFocus predicate device are substantially equivalent and have the same intended use.

CardioFocus, Inc. believes the minor differences of the CardioFocus Malleable Surgical Lightstic" 180 and its predicate Surgical Lightstic™ 180 fiber laser accessories should not raise any concerns regarding the overall safety and effectiveness.

#### Performance Data

None required.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress. The profiles are arranged in a row, with each one slightly overlapping the previous one. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

MAR 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CardioFocus, Inc. c/o Mr. Joseph Curtis Vice President of Clinical and Regulatory Affairs 10 Commerce Way Norton, MA 02766

Re: K013901 Trade/DeviceName: Malleable Surgical Lightstic TM 1 80 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: GEX, OCL Dated: November 21. 2001 Received: November 26, 2001

Dear Mr. Curtis:

This letter corrects our substantially equivalent letter of December 20, 2001.

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 (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 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.

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## Page 2 - Mr. Joseph Curtis

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 (OS) 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 continue 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, "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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

elmoe

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

KD13901 510(k) Number (if known):

Device Name:

Malleable Surgical Lightstic™ 180

Indications For Use:

Coagulation of Cardiac Tissue

These are identical indications to the already cleared indications for market Note: release in K011988.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyt Plurdy
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K013901
OR Over-The-Counter Use

Prescription Use (Per 21 CFR §801.109)