(86 days)
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
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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report with explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implied by the performance characteristics of the predicate device, and the "device performance" is stated in qualitative terms.
| Acceptance Criterion (Implied by Predicate Performance) | Reported Device Performance (Laparoshield Conditioned Insufflation Set) |
|---|---|
| Ability to heat a gas stream | Functions as intended (implies heating capability) |
| Ability to humidify a gas stream | Functions as intended (implies humidifying capability) |
| Ability to filter a gas stream | Functions as intended (implies filtering capability) |
| Maintain specified flow rates | Testing performed includes flow rate evaluation |
| Maintain specified temperature | Testing performed includes temperature evaluation |
| Maintain specified humidity | Testing performed includes humidity evaluation |
| Compatibility with CO2 gas | Indicated for use with CO2 |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices or experimental runs. The text mentions "Testing was performed to evaluate the flow rate, temperature and humidity at two different per minute average CO2 flow rates." This indicates at least two flow rate conditions were tested, but not the number of units tested or repetitions.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal to Pall Medical, the manufacturer. The study is retrospective in the sense that it's a verification and validation study conducted by the manufacturer before submission for market clearance, rather than a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. This type of device (a gas conditioning set) does not typically involve expert review for "ground truth" in the same way an imaging AI algorithm might. The performance criteria (flow, temperature, humidity) are objectively measurable physical properties.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" for the performance metrics (flow rate, temperature, humidity) is established by direct physical measurement using calibrated equipment, not by subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device aims to assist or improve their performance. The Laparoshield Conditioned Insufflation Set is a device accessory that performs physical conditioning of gas, not a diagnostic tool for human interpretation.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: Not applicable in the context of an "algorithm only" device. This device is a mechanical/electrical accessory that operates independently to condition gas. Its performance is inherent to its design and function, not dependent on an algorithm interpreting data. The performance testing described (flow rate, temperature, humidity) is its standalone performance without human intervention in the conditioning process itself.
7. Type of Ground Truth Used:
- Ground Truth Type: The ground truth for this device's performance is based on objective physical measurements of flow rate, temperature, and humidity, presumably against established engineering specifications or industry standards for optimal insufflation gas conditioning.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a hardware device with defined physical characteristics.
9. How Ground Truth for Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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: (516) 484-5400 Facsimile: (516) 484-3672
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®")
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{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. Brogdon
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 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
\\DC - 63343/0001 - 1683925 v1
§ 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.