(66 days)
The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respiratory or physiological problems where the requirement for supplemental oxygen therapy is indicated by a qualified physician or registered healthcare professional. The PDOC is indicated for use in both the hospital and home care environment where a demand oxygen delivery system is indicated.
The PDOC allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
This document, a 510(k) premarket notification letter for the Salter Labs Pneumatic Demand Oxygen Conserver (PDOC), does not contain the information requested in your prompt.
The document primarily focuses on:
- A letter from the FDA confirming substantial equivalence to a predicate device.
- The product code correction (from 73 BZD to 73 NFB).
- General regulatory information regarding medical devices.
- The Indications for Use statement for the PDOC.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets, data provenance, or details about the study population.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter, not a detailed technical study report or clinical trial summary that would typically contain such performance and validation data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. Duane Kazal Salter Labs 100 W. Sycamore Road Arvin, CA 93203-2300
Re: K990678
Pneumatic Demand Oxygen Conserver Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Kazal:
This letter corrects our substantially equivalent letter of May 7, 1999, regarding the Pneumatic Demand Oxygen Conserver. Our letter identified the product code as 73 BZD. This is in error, the correct product code is 73 NFB as indicated above.
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. Duane Kazal
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 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) 594-4648. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dork Tella
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SALTER LABS
2.5 Indications For Use: Salter Labs Pneumatic Demand Oxygen Conserver
The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respirations The Satter Labs Fileumatic Demark Oxyger Consor of Concernal Oxygen therapy is indicated of puysionelia prodetils where the required to required in The PDOC is indicated for use in by a qualified physicial of registered noment where a demand oxygen delivery system is indicated.
The PDOC allows for the effective administration of high pressure medical grade or The FDOC anows for the circulty a patient who has been diagnosed as requiring and which concentrated oxygen administration by a parent the sician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Charlie Cho for AAC (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K990678 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) ✓ | (Optional Format 1-2-96) |
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G SALTER LABS
2.5 Indications For Use: Salter Labs Pneumatic Demand Oxygen Conserver
The Salter Labs Pneumatic Demand Oxygen Conserver (PDOC) is indicated for all respiratory or physiological problems where the requirement for supplemental oxygen therapy is indicated by a qualified physician or registered healthcare professional. The PDOC is indicated for use in both the hospital and home care environment where a demand oxygen delivery system is indicated.
The PDOC allows for the effective administration of high pressure medical grade or concentrated oxygen upon demand to a patient who has been diagnosed as requiring and which has been prescribed oxygen administration by a physician. Oxygen is administered only during the inhalation cycle, conserving oxygen during the exhalation cycle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Charlie Cho for AAC (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | |
|---|---|
| 510(k) Number | K990678 |
| Prescription Use (Per 21 CFR 801.109) ✓ | OR | Over-The-Counter Use ______ (Optional Format 1-2-96) |
|---|---|---|
| ----------------------------------------------------------------- | ---- | ------------------------------------------------------ |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).