(79 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.
picoSAT II SpO2 pulse oximetry module and M3001A Multi-Measurement Server
The provided text is a 510(k) summary for the picoSAT II SpO2 pulse oximetry module. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does NOT contain the detailed information required to fill out the table regarding acceptance criteria and the specific study proving the device meets those criteria.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. Pulse oximeter performance is typically measured by accuracy (Arms) over a specified SpO2 range.
- Reported Device Performance: Not explicitly stated. The document mentions "clinical validation studies were also conducted" but does not provide the results of these studies or any performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable, as this is a pulse oximetry device, not an image-based diagnosis device usually requiring expert interpretation for ground truth. The "ground truth" for a pulse oximeter would likely be arterial blood gas measurements (co-oximetry).
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable for a pulse oximetry device where direct physiological measurements usually serve as the reference.
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
- MRMC Study: Not applicable. This is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The core of a pulse oximeter is a standalone algorithm. The document mentions "clinical validation studies were also conducted," which would imply testing the device's accuracy in measuring SpO2. However, no specific performance results (like Arms) are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated, but for pulse oximeters, the gold standard for ground truth is typically arterial blood gas analysis (co-oximetry).
8. The sample size for the training set
- Sample Size (Training Set): Not mentioned. "Training set" is generally more relevant for machine learning algorithms. While the device uses a "FAST pulse oximetry algorithm," the document doesn't detail how this algorithm was developed or if it involved a distinct "training set" in the modern machine learning sense. Clinical validation would be a more direct performance test.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not mentioned.
Summary of what is present and what is missing:
The provided text serves as a 510(k) summary, which generally focuses on demonstrating substantial equivalence to predicate devices and adherence to regulatory requirements. It confirms that "clinical validation studies were also conducted" and "all verification and validation activities were successfully completed," but it explicitly lacks the detailed results, acceptance criteria, sample sizes, and ground truth methodologies that would typically be found in a detailed study report or a more comprehensive technical document.
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FEB 1 3 2004
8.0 510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: David Osborn Philips Medical Systems Cardiac & Monitoring Systems 3000 Minuteman Road Andover, MA 01810-1099 978 659 3178 Fax: 978 685 5624 Tel: e-mail: dave.osborn@philips.com
This summary was prepared on November 24, 2003.
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- The name of the device is the picoSAT II SpO2 pulse oximetry module. Classification names are as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Anesthesiologyand RespiratoryTherapy (12624) | §870.2700, II | DQA | Oximeter |
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The new device is substantially equivalent to previously cleared Philips devices M3001A and picoSAT module marketed pursuant to K030973 and K021330 as well as the Masimo SET pulse oximeter marketed pursuant to K031330 and K013792.
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The modification improves the performance of the FAST pulse oximetry algorithm.
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The new devices have the same intended use as the legally marketed predicate devices. When used in the hospital or patient transport environments, they are intended for the monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates.
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The new devices have the same technological characteristics as the legally marketed predicate devices.
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Verification testing activities were conducted to establish the performance and reliability characteristics of the new device. Testing involved functional level tests and safety testing from the risk analysis. Clinical validation studies were also conducted. All verification and validation activities were successfully completed.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 1 3 2004
Mr. David Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099
Re: K033715
Trade/Device Name: PICOSAT II SPO2 Pulse Oximetry Module Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DPZ Dated: January 29, 2004 Received: January 30, 2004
Dear Mr. Osborn:
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 (sec 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.
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.
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Page 2 - Mr. David Osborn
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 yours,
Susan Raasch
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): K033715
picoSAT II SpO2 pulse oximetry module and M3001A Multi-Device Name: Measurement Server
Indications for Use:
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and hospital environments.
Prescription Use ves (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S. Ananth
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).