(86 days)
Not Found
Not Found
No
The device description and performance studies focus on basic heating and humidification control based on temperature sensing, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
The device is described as affecting the condition of the insufflation gas (heating, humidifying, filtering), which directly relates to patient physiological safety and comfort during laparoscopic surgery, making it a therapeutic accessory.
No
This device is an accessory to an insufflator, designed to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. Its function is conditioning the gas, not diagnosing any medical condition.
No
The device description clearly outlines physical components such as heating wire, temperature control unit, power supply, hydrating wick, tubing, and a temperature strip, indicating it is a hardware device with integrated control.
Based on the provided information, the Laparoshield Conditioned Insufflation Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device description details components that interact with the gas being delivered to the patient's body cavity during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Laparoshield Conditioned Insufflation Set's function is to prepare a gas for surgical use, which falls outside the scope of IVD.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
85 HIF
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Georgia BioMedical System, Inc.'s Filter Heater/Hydrator Insufflation Gas Conditioner ("Insuflow®")
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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
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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
\\DC - 63343/0001 - 1683925 v1