(318 days)
Not Found
Not Found
No
The summary describes a mechanical breathing circuit system with a filter and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device facilitates the administration of medical gases during anesthesia and filters viral and bacterial contamination, but it does not directly treat a disease or condition.
No
The device is an anesthesia breathing circuit system with a filter, designed for administering medical gases and minimizing contamination during anesthesia. Its function is to facilitate gas delivery and maintain hygiene in the breathing circuit, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as a breathing system filter, face mask, tubing, and reservoir bag, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the administration of medical gases during anesthesia." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The components described (breathing circuit, filter, mask, tubing, reservoir bag) are all involved in delivering gases to and from the patient and filtering the air. They are not used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The primary function is gas delivery and filtration.
Therefore, the Pall Ultipor Anesthesia Breathing Circuit System is a medical device used in patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pall Ultipor Anesthesia Breathing Circuit System ("Ultipor") 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%.
Product codes
CAH
Device Description
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zefon Anesthesia Breathing System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG 0 1 2002
K013093
510(k) Summary
| Submitted by | Pall Medical
2200 Northern Blvd.
East Hills, NY 11548-1209 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 516-484-5400 ext. 4341
Fax: 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 Circuit
System with Bacterial System filter |
| Common Name: | Breathing Circuit |
| Predicate Device: | Zefon Anesthesia Breathing System |
| Indications: | The Pall Ultipor Anesthesia Breathing Circuit
System ("Ultipor") 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%. Zefon Anesthesia Breathing System
("Zefon") has virtually the same indications. |
| Technological Characteristics: | 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 |
| Conclusion: | The device is substantially equivalent to the |
| | predicate. |
1
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.
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 emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The figure is composed of three curved lines that suggest the wings and body of the bird.
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.
3
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
4
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)