(318 days)
The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.
Both the Ultipor and Zefon consist of a patient kit and a machine kit. The components of the both Ultipor's and Zefon's patient kits are: (1) the BSF; (2) face mask; and (3) mask elbow. The components of both Ultipor's and Zefon's machine kit are: (1) the reservoir bag; (2) expiratory tubing; and (3) inspiratory tubing. Ultipor and Zefon both have a gas monitoring line; this line is a component of Ultipor's machine kit and Zefon's patient kit. Both devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).
In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits.
The provided text does not contain detailed information about specific acceptance criteria and a study proving device performance in the way typically found for AI/ML medical devices. The document is a 510(k) summary for a medical device (Pall Ultipor Anesthesia Breathing Circuit System with Bacterial System filter) seeking clearance based on substantial equivalence to a predicate device.
However, based on the information provided, I can extract and infer some aspects.
Key Information from the Document:
The primary performance claim and, therefore, implied acceptance criterion, mentioned in the "Indications" and "Technological Characteristics" sections, is:
- "The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%."
The document states "The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use." This implies a study was conducted to demonstrate this, but no specifics about the study design, sample size, or results are provided in this summary.
Attempting to answer your questions based only on the provided text:
- Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Minimum viral and bacterial contamination efficiency of 99.999% | "minimizes viral and bacterial contamination... with a minimum efficiency of 99.999%." |
| Durability of gas monitoring line for 24-hour/multiple patient use (if applicable, though explicitly stated as "does not raise new questions of safety or effectiveness") | "The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use." |
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Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "The 510(k) includes data," implying internal testing rather than external or clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This device is a physical breathing circuit with a filter, not an AI/ML algorithm requiring expert interpretation for ground truth. Performance would be assessed through laboratory testing, e.g., microbial challenge testing for filter efficiency.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/ML device, so an MRMC study is not relevant. The substantial equivalence argument is based on similar physical components and performance claims to a predicate device, not on assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance of the filter (99.999% efficiency) would be a standalone measurement.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the 99.999% filtration efficiency claim, the ground truth would typically be established through laboratory testing, likely using standardized methods for microbial challenge or particle filtration efficiency, with the results empirically measured against established criteria.
- For the durability of the gas monitoring line, it would be engineering or functional testing to ensure it withstands 24-hour/multiple use conditions.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary: The provided document is a 510(k) summary for a physical medical device. It makes a performance claim regarding bacterial/viral filtration efficiency and mentions data supporting the durability of a gas monitoring line. However, it does not detail the specifics of any studies (like sample sizes, methods for ground truth, or expert involvement) as would be typical for an AI/ML device submission. The substantial equivalence argument relies on comparing the device's characteristics and performance to an already cleared predicate device, rather than providing extensive de novo study details in this summary.
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AUG 0 1 2002
K013093
510(k) Summary
| Submitted by | Pall Medical2200 Northern Blvd.East Hills, NY 11548-1209 |
|---|---|
| Phone: 516-484-5400 ext. 4341Fax: 516-484-3672 | |
| Contact Person: | Leonard S. Berman, Ph.D.Director of Scientific Affairs |
| Date: | August 1, 2002 |
| Device Trade Name: | Pall Ultipor™ Anesthesia Breathing CircuitSystem with Bacterial System filter |
| Common Name: | Breathing Circuit |
| Predicate Device: | Zefon Anesthesia Breathing System |
| Indications: | The Pall Ultipor Anesthesia Breathing CircuitSystem ("Ultipor") with a Breathing System Filter("BSF") is intended for use in the administration ofmedical gases during anesthesia. The circuitconnects the anesthesia gas machine to the patient,by means of an oronasal facemask or by aconnection to an artificial airway, such as anendotracheal tube or laryngeal mask. The PallUltipor 25 BSF minimizes viral and bacterialcontamination of the inspiratory and expiratorylimbs of the circuit with a minimum efficiency of99.999%. Zefon Anesthesia Breathing System("Zefon") has virtually the same indications. |
| Technological Characteristics: | Both the Ultipor and Zefon consist of a patient kitand a machine kit. The components of the bothUltipor's and Zefon's patient kits are: (1) the BSF;(2) face mask; and (3) mask elbow. The componentsof both Ultipor's and Zefon's machine kit are: (1)the reservoir bag; (2) expiratory tubing; and (3)inspiratory tubing. Ultipor and Zefon both have agas monitoring line; this line is a component ofUltipor's machine kit and Zefon's patient kit. Both |
| Conclusion: | The device is substantially equivalent to the |
| predicate. |
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devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).
In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits. The use of Ultipor's reservoir bag. expiratory/inspiratory tubing, and expiratory connector for up to 24 hours on multiple patients does not raise any new questions of safety or effectiveness because FDA has already cleared the same types of components for the same duration of use as part of the Zefon device. The gas monitoring line is the only component that has different durations of use in the Ultipor (24 hour/multiple use) than in the Zefon (single use). The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use. Thus, the use of Ultipor's gas monitoring lines for multiple uses for up to 24 hours does not raise any new questions of safety or effectiveness when compared to the cleared predicate.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Pall Medical C/O Mr. Jonathan S. Kahan Partner Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K013093
Trade/Device Name: Pall Ultipor Anesthesia Breathing System Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: May 6, 2002 Received: May 9, 2002
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.
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Page 2 - Mr. Kahan
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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). 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.qov/cdrh/dsma/dsmamain.html
Sincerely,
Timo Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Pall Ultipor Anesthesia Breathing Circuit System
Indications for Use:
The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient, by means of an oronasal facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6HWesterholm
ision Sign-Off Division of Dental, Infection Control. and General Hospital Device 510(k) Number
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).