(329 days)
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The description focuses on oxygen conservation and regulation, which are generally achieved through mechanical or electronic control systems, not AI/ML.
No
The device is an oxygen conservation device that regulates oxygen supply and consumption, which supports a therapeutic process but is not a therapeutic device itself. Its predicate device is an oxygen delivery system, further indicating its supportive function rather than a direct therapeutic action on the body.
No
The device, SANPO, is described as an oxygen conservation device intended to conserve and regulate oxygen supply. There is no mention of it being used to diagnose any medical condition.
No
The device description explicitly states it is an "oxygen conservation device" intended for use "in conjunction with oxygen supply systems," implying a physical device that interacts with oxygen flow, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for conserving and regulating oxygen supply and consumption in conjunction with portable oxygen supply units. This is a therapeutic or life-support function, not a diagnostic one.
- Device Description: The description reinforces its function as an oxygen conservation device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
- For use by adults in conjunction with portable oxygen supply units to conserve and regulate oxygen supply and consumption. SANPO is not intended for use by neo-natal or pediatric patients.
Product codes
73 NFB
Device Description
oxygen conservation device, SANPO, which is intended for use in conjunction with oxygen supply systems to conserve and regulate oxygen supply and consumption
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
adults only, and not neo-natal or pediatric patients.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
96454
XIV. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
SEP 26 1997
Koike is submitting a 510(k) premarket notification for its oxygen conservation device, SANPO, which is intended for use in conjunction with oxygen supply systems to conserve and regulate oxygen supply and consumption. SANPO is intended for use by adults only, and not neo-natal or pediatric patients. Koike is claiming substantial equivalence to the oxygen conservation component of the PULSAIR® I and II liquid oxygen delivery systems manufactured by the CRYO, Corp. and cleared by the Food and Drug Administration under Section 510(k) on December 5, 1983 (K833994). The SANPO is substantially similar in its intended use, operational principles and product features to the oxygen conservation component of the PULSAIR I and II.
To support the substantial equivalence to the predicate products, the physical and technical characteristics of the SANPO have been compared to the oxygen conservation component of the PULSAIR I and II.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head facing right, with its beak and feathers depicted in a simplified, abstract manner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Koike Medical Co. c/o Mr. Stephen Paul Mahinka Morgan, Lewis and Bockius LLP 1800 M Street, N.W. Washington, DC 20036-5869
K964541 Re:
SANPO I Oxygen Conserving Device Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Mahinka:
This letter corrects our substantially equivalent letter of September 26, 1997, regarding the I mis lease over conserving Device. 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 for are researce or 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 may or daily 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.
2
Page 2 - Mr. Stephen Paul Mahinka
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 that I Dri has made a acterinations administered by other Federal agencies. You must or any I odetar backed and the ments, including, but not limited to: registration and listing (21 Compry with an the Net 810 cart 801); good manufacturing practice requirements as set CI K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the qualion 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) I mis letter will and w you to organization of substantial equivalence of your device to a legally prematics notification. The Pro Printings of the sification 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 11 you desire specific acrisoner for in vitro diagnostic devices), please contact the Office of additionally 21 CHT Far 80718 Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1016. The Office of Compliance at (301) 594-4639. Also, please note the your de reserved, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outcr general intermation of Small onal 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,
Dellittell
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
R 96454 STATEMENT OF INDICATIONS FOR USE
Device Name: SANPO
.
Indications for Use:
- For use by adults in conjunction with portable oxygen supply units to conserve and regulate oxygen supply and consumption. SANPO is not intended for use by neo-natal or pediatric patients.
Christy Laurian for HAC
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .
Prescription Use [X]
OR Over-The-Counter Use __
WA01A/66236.1