LAPAROSHIELD CONDITIONED INSUFFLATION SET

K030469 · Pall Medical · HIF · May 9, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K030469
• Device Name: LAPAROSHIELD CONDITIONED INSUFFLATION SET
• Applicant: Pall Medical
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Laparoshield Conditioned Insufflation Set and its predicate device are intended to be used as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. It is indicated for use with CO2.

Device Story

Laparoshield Conditioned Insufflation Set functions as accessory to laparoscopic insufflator; heats, humidifies, and filters CO2 gas stream. Device consists of silicon-coated heating wire coiled within insufflation tubing; patient-end wire encased in hydrating wick. Gas flows through annulus between wick and outer tubing; heat/humidity transfer occurs via proximity. Integrated temperature control unit in power supply manages heating; temperature strip provides visual feedback (under/normal/over). Universal connector ensures compatibility with standard insufflation machines (Luer, 15mm/22mm ISO 5356-1, hose-barb) and trocars. Used in clinical laparoscopic surgery settings; operated by surgical staff. Benefits patient by delivering conditioned gas to surgical site.

Clinical Evidence

Bench testing only. Evaluated flow rate, temperature, and humidity at two different per-minute average CO2 flow rates. Device functioned as intended in all instances.

Technological Characteristics

Silicon-coated heating wire; hydrating wick; temperature control unit; temperature indicator strip. Universal connectors (Luer, 15mm/22mm ISO 5356-1, hose-barb).

Indications for Use

Indicated for use as an accessory to an insufflator to heat, humidify, and filter CO2 gas during laparoscopic surgery.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• Georgia BioMedical System, Inc.'s Filter Heater/Hydrator Insufflation Gas Conditioner ("Insuflow®")

Submission Summary (Full Text)

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K030.469

MAY - 9 2003

# 510(k) SUMMARY

# Pall Medical's Laparoshield Conditioned Insufflation Set

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

Pall Medical 2200 Northern Boulevard East Hills, NY 11548-1209

Phone: [phone] Facsimile: [phone]

Contact Person: Leonard S. Berman, PhD

Date Prepared: February 7, 2003

## Name of Device and Name/Address of Sponsor

Laparoshield Conditioned Insufflation Set

Pall Medical 2200 Northern Boulevard East Hills, NY 11548-1209

### Common or Usual Name

Laparoscopic Insufflator

### Classification Name

Laparoscopic Insufflator

### Predicate Devices

Georgia BioMedical System, Inc.'s Filter Heater/Hydrator Insufflation Gas Conditioner ("Insuflow®")

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### Intended Use / Indications for Use

The Laparoshield Conditioned Insufflation Set and its predicate device are intended to be used as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. It is indicated for use with CO2.

#### Technological Characteristics

The Laparoshield Conditioned Insufflation Set consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a temperature control unit integrated into the power supply component of the device. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.

#### Performance Data

Testing was performed to evaluate the flow rate, temperature and humidity at two different per minute average CO2 flow rates. In all instances, the Laparoshield Conditioned Insufflation Set functioned as intended.

### Substantial Equivalence

The Laparoshield Conditioned Insufflation Set and the Insuflow® have the same intended use, which is as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. The devices have very similar technical characteristics. The minor technological differences do not present new issues of safety or effectiveness. Thus, the Laparoshield Conditioned Insufflation Set is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

Pall Medical % Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109 Re: K030469

Trade/Device Name: Laparoshield® Conditioned Insufflation Set Regulation Number: 21 CFR 884.1730 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HIF Dated: February 11, 2003 Received: February 12, 2003

Dear Mr. Kahan:

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.

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); 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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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

12317469 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Laparoshield Conditioned Insufflation Set

Indications for Use:

The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with CO2

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

David R. Legum

(Division Sign-Off) Division of Reprodu and Radiological De 510(k) Number

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