(366 days)
The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.
The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding silicone cannula tips that fit into the infant's nares. Continuous flow circulates through the coaxial pouch under positive pressure from which the patient breathes via the cannula. The distal end of the pouch has a swivel adapter with three external ports and one external port. One external port is for pressure and the other two are in-flow and out-flow ports which are bi-directional. The internal port on the swivel adapter is the connection for the internal tube leading to the proximal cannula to minimize dead space.
The provided text is a 510(k) Summary for the Clarissa™ Infant nCPAP Cannula (K032922). It describes a medical device, and the data provided focuses on demonstrating substantial equivalence to predicate devices rather than detailing a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics and statistical analyses typically associated with AI/software devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory document for a physical medical device. The document emphasizes performance equivalency through physical testing rather than algorithmic performance evaluation.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available or not applicable:
Acceptance Criteria and Study Details for Clarissa™ Infant nCPAP Cannula (K032922)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Essentially equivalent flow resistance to predicate devices | "provides essentially equivalent flow resistance" |
| Essentially equivalent dead space volume to predicate devices | "provides essentially equivalent... dead space volume" |
| Functional equivalence to predicate devices (general performance) | "performance is essentially equivalent to the above listed predicate devices" |
| Appropriate for continuous positive airway pressure (CPAP) administration on continuously monitored neonatal and infant patients in the hospital/institutional environment. | Intended Use (as described) is supported by testing demonstrating equivalency to devices with this intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "test data" but does not give specific numbers of devices or tests performed.
- Data Provenance: Not specified, but generally, such tests are conducted in-house by the manufacturer or by third-party testing labs. Given the nature of physical device testing, it would be prospective, directly testing the Clarissa™ device.
- Country of Origin: The manufacturer, Airways Development, LLC, is based in Kenilworth, NJ, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical device; its performance is assessed through objective physical measurements (like flow resistance and dead space volume) rather than subjective expert interpretation for ground truth.
4. Adjudication method for the test set
- Not Applicable. See explanation above. Physical measurements are typically compared directly to established benchmarks or predicate device results, not adjudicated by experts in the context of ground truth.
5. 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
- Not Applicable. This is a physical medical device, not an AI or software device involving human readers or interpretation of data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Ground Truth: For performance metrics like "flow resistance" and "dead space volume," the "ground truth" would be the objective physical measurements obtained from testing the Clarissa™ device and comparing them to measurements from the legally marketed predicate devices. The equivalence to predicate device performance is the basis for regulatory clearance.
8. The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
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SEP 2 2 2004
510(k) Summary of Safety and Effectiveness Airways Development, LLC Clarissa™ Infant nCPAP Cannula (K032922)
| Submitted By: | Airways Development, LLC209 North 14th StreetKenilworth, NJ 07033 |
|---|---|
| Date: | September 20, 2004 |
| Contact Person: | Robert LandisVice President, Product DevelopmentAirways Development, LLC209 North 14th StreetKenilworth, NJ 07033Tel: (908) 931-1333Fax: (908) 931-0034 |
| Proprietary Name: | Clarissa Infant n-CPAP Cannula |
| Common Name: | Infant CPAP Nasal Cannula |
| Classification Name and Reference: | Ventilator, Continuous, Facility Use21CFR 868.5895 |
| Device Product Code and Panel Code: | CBKAnesthesiology Panel |
| Predicate Devices: | Argyle CPAP Nasal Cannula (K811409)Neotech Binasal Airway (K792018)Medicomp CPAP Nasal Cannula (K861280)Hudson Infant Nasal CPAP Cannula (K871157)Ackrad Infant Nasal Cannula (K895031) |
Device Description:
The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding silicone cannula tips that fit into the infant's nares. Continuous flow circulates through the coaxial pouch under positive pressure from which the patient breathes via the cannula. The distal end of the pouch has a swivel adapter with three external ports and one external port. One external port is for pressure and the other two are in-flow and out-flow ports which are bi-directional. The internal port on the swivel adapter is the connection for the internal tube leading to the proximal cannula to minimize dead space.
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Intended Use:
The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.
Technological Characteristics
The Clarissa"™ Infant nCPAP Cannula is a patient interface designed to be used with continuous flow CPAP circuits or ventilators in the continuous flow CPAP mode. The cannula tips are inserted into the nasal passage to affect a seal for the continuous flow to produce CPAP.
The air input end has a swivel adapter that connects to 10mm breathing circuits. During actual use the wide part of the pouch lays on the infant's forehead and the narrow portion extends down to the nasal openings where cannula tips protrude out of the pouch at a 90 degree angle. The device has built-in attachment loops to facilitate attachment to head bonnet.
The device material is a soft expandable and flexible medical grade silicone. The only materials to contact the patient are the silicone cannula and polyurethane foam head bonnet.
Performance Data
The test data submitted demonstrates that the proposed Clarissa Infant nCPAP Cannula performance is essentially equivalent to the above listed predicate devices. Testing completed shows devices provide essentially equivalent flow resistance and dead space volume.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP 2 2 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Airways Development, LLC C/O Mr. Richard J. Larkin Regulatory Affairs Consultant R.J. Larkin Consulting, Incorporated 209 North 14th Street, P.O. Box Kenilworth, New Jersey 07033-0496
Re: K032922
Trade/Device Name: Clarissa™ Infant nCPAP Cannula Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 14, 2004 Received: September 15, 2004
Dear Mr. Larkin:
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. Larkin
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), please contact the Office of Compliance at (301) 594-4646. 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 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 vours.
Susan Rumm
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known): K032922
Device Name: Clarissa™ Infant nCPAP Cannula
Indications For Use: The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cecefybleen
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device Page 1 of 1 510(k) Number:
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).