(30 days)
Not Found
Not Found
No
The device description focuses on hardware components (heating wire, power supply, wick) and basic temperature control. There is no mention of AI, ML, or any data-driven algorithms for control or analysis.
No
The device is an accessory to an insufflator, used to heat, humidify, and filter a gas stream for insufflation during laparoscopic surgery. It modifies the gas for a procedure but does not directly treat a disease or condition itself.
No
Explanation: The device is described as an accessory to an insufflator that heats, humidifies, and filters a gas stream. Its function is to prepare gas for insufflation, and it does not perform any diagnostic measurements or analysis of the patient's condition.
No
The device description clearly outlines physical components such as heating wire, power supply, tubing, wick, temperature strip, and connectors, indicating it is a hardware device with electrical and mechanical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Laparoshield is used during laparoscopic surgery to condition the gas used for insufflation. It directly interacts with the patient's body cavity by delivering the conditioned gas.
- Intended Use: The intended use clearly states it's an accessory to an insufflator for use during laparoscopic surgery.
The device's function and intended use are entirely focused on supporting a surgical procedure performed on the patient, not on analyzing samples taken from the patient.
N/A
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.
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.
Product codes
85 HIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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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.
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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 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