(30 days)
The modified Laparoshield Conditioned Insufflation Set ("Laparoshield") is 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.
The modified Laparoshield consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a constant voltage/voltage limited power supply. 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.
The Pall Medical Laparoshield Conditioned Insufflation Set is described as an accessory to an insufflator designed to heat, humidify, and filter a CO2 gas stream for laparoscopic surgery. The document provides information regarding its technological characteristics and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature and Humidity Output: No specific numerical acceptance criteria are provided in the document. The general acceptance criterion implied is that the device must meet its internally defined "performance specifications" for temperature and humidity output. | "In all instances, the modified Laparoshield met its performance specifications." The device demonstrated the ability to warm and humidify CO2. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates." No specific sample size (i.e., number of units tested) for the test set is provided. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be bench testing conducted by Pall Medical as part of their premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing described is bench testing of physical parameters (temperature and humidity output), not a clinical study involving expert assessment of images or patient outcomes. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was bench testing of physical characteristics, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes bench testing of a medical device, not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was conducted in the form of bench testing. The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates. In all instances, the modified Laparoshield met its performance specifications." This directly assesses the device's performance without human interaction in its function.
7. Type of Ground Truth Used
The ground truth used was the predefined performance specifications for temperature and humidity output established by Pall Medical for the device. This is based on physical measurements against engineering design requirements, not clinical ground truth like pathology or expert consensus.
8. Sample Size for the Training Set
Not applicable. This device is a hardware accessory with heating and humidifying functions; it is not software or an AI algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
K033991
Page 1 of 2
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
(516) 484-5400 Phone: Facsimile: (516) 484-3672
Leonard S. Berman, PhD Contact Person:
December 23, 2003 Date Prepared:
Name of Device and Name/Address of Sponsor
Laparoshield Conditioned Insufflation Set
Pall Medical J 2200 Northern Boulevard East Hills, NY 11548-1209
Common or Usual Name
Laparoscopic Insufflator
Classification Name
Laparoscopic Insufflator
Predicate Devices
Laparoshield Conditioned Insufflation Set
Intended Use / Indications for Use
The modified Laparoshield Conditioned Insufflation Set ("Laparoshield") is 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.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a handwritten signature or text, which appears to be in cursive. The text is somewhat faded and has a rough, textured appearance, suggesting it may be a scan or copy of an original document. The signature is illegible, but it seems to contain a combination of loops, curves, and possibly some distinct letterforms.
Technological Characteristics
The modified Laparoshield consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a constant voltage/voltage limited power supply. 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 temperature and humidity output at two different per minute average CO2 flow rates. In all instances, the modified Laparoshield met its performance specifications.
Substantial Equivalence
The modified Laparoshield and the cleared Laparoshield 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 are identical except for their heating control features and a material in two components. These minor technological differences do not present new issues of safety or effectiveness. Moreover, bench tests show that the modified Laparoshield is as safe and effective as the cleared Laparoshield, which has the same performance specifications. Thus, the modified Laparoshield is substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pall Medical % Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K033991
JAN 2 2 2004
Trade/Device Name: Laparoshield Conditioned Insufflation Set Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: 85 HIF Dated: December 23, 2003 Received: December 23, 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 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 docs 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.
{3}------------------------------------------------
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
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 A. Dejonon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
\ \DC - 63343/0001 - 1847600 v3
§ 884.1730 Laparoscopic insufflator.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 § 884.9.