(117 days)
No
The summary describes a standard pulse oximetry module and does not mention any AI or ML capabilities. The performance metrics and testing described are typical for a physiological monitoring device.
No
The device is indicated for monitoring, not for providing therapy or treatment.
No
The device is indicated for monitoring, recording, and alarming of physiological parameters, not for diagnosis. While it provides data that can be used for diagnosis, its primary function is monitoring.
No
The device description explicitly states it is a "picoSAT II SpO2 pulse oximetry module," which is a hardware component designed for use in host patient monitors. The performance studies also mention functional and safety testing, which are typical for hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring physiological parameters of patients (SpO2 and pulse rate) in a clinical setting. This involves measuring parameters directly from the patient's body, not from in vitro samples like blood, urine, or tissue.
- Device Description: It's a pulse oximetry module for use in host patient monitors. Pulse oximetry is a non-invasive method of measuring oxygen saturation in the blood.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside of the body, using reagents, or performing tests on biological specimens in a laboratory setting, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
DQA, DPZ
Device Description
The modification creates the picoSAT II SpO2 pulse oximetry module for use in host patient monitors.
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, pediatrics, and neonates
Intended User / Care Setting
health care professionals / hospital or patient transport environments
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971910, K990972, K000822, K013199, K021300
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KO309B
JUL 2 8 2003
| 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. | |||
| 1. The submitter of this premarket notification is: | |||
| David Osborn | |||
| Philips Medical Systems | |||
| Cardiac & Monitoring Systems | |||
| 3000 Minuteman Road | |||
| Andover, MA 01810-1099 | |||
| Tel: 978 659 3178 | Fax: 978 685 5624 | ||
| e-mail: d.g.osborn@ieee.org | |||
| This summary was prepared on July 15, 2003. | |||
| 2. The name of the device is the picoSAT II SpO2 pulse oximetry | |||
| module. Classification names are as follows: | |||
| Device Panel | Classification | ProCode | Description |
| Anesthesiology | |||
| and Respiratory | |||
| Therapy (12624) | §870.2700, II | DQA | Oximeter |
| 3. The new device is substantially equivalent to previously cleared | |||
| Philips devices M3000A & M3001A marketed pursuant to K971910, K990972, | |||
| K000822, K013199, and K021300. | |||
| 4. The modification creates the picoSAT II SpO2 pulse oximetry module for | |||
| use in host patient monitors. | |||
| 5. picoSAT II SpO2 pulse oximetry module specifications. | |||
| Item | Specification | ||
| SpO2 Algorithm | Philips FAST SpO2 algorithm | ||
| motion and low perfusion tolerant | |||
| SpO2 displayed range | 0% to 100% | ||
| SpO2 accuracy (functional) over | |||
| the range of 70% to 100% for | |||
| neonates through adults | |||
| (reusable probes) | M1191A and M1192A: ± 2.5% | ||
| M1193A and M1195A: ± 3.0% | |||
| M1194A: ± 3.0% (adult only) | |||
| SpO2 accuracy (functional) over | |||
| the range of 70% to 100% for | |||
| adults and neonates | |||
| (disposable probes) | M190xA and Nellcor®: ±3.0% | ||
| SpO2 parameter resolution | 1% | ||
| Pulse Rate parameter range & | |||
| resolution | 30 bpm to 300 bpm ±2% or 1 bpm whichever is | ||
| greater | |||
| FAST SpO2 parameter averaging | 5 s to 20 s | ||
| SpO2 parameter data update | |||
| period | 1 s | ||
| Pleth wave height requirement | 32 pixels, minimum | ||
| Input power | 1.8 V to 11.5 Vdc, 300 mW max | ||
| Serial data interface | 3/5 V logic levels, switchable |
'
8-bit word with stop, start & parity bit
1
| Item | Specification |
|---|---|
| Perfusion Indicator | An indicator of SpO₂ signal quality |
0.3 indicates that >95% of the time
signals are good enough for valid
measurements.
At 0, no measurement is made. |
| NBP cuff inflation detection
suppression of SpO2 INOPs &
parameter output | SpO₂ and pulse rate parameter output and the
SpO₂ Non-pulsatile and Pleth Non-pulsatile
INOPS are suppressed for adjustable period
of 30 s to 60 s when picoSAT II SpO2 pulse
oximetry module detects that an NBP
measurement is in progress. SpO2 EXTD.
UPDATE INOP generated after 30 s of
suppression. |
| Technical alarm conditions
(INOPS) | Generates the following technical alarm
conditions:
SpO₂ EQUIP MALF
SpO₂ TEST SIGNAL
SpO₂ SENSOR MALF
NO SpO₂ SENSOR
SpO₂ INTERFERENCE
SpO₂ LEARNING
SpO₂ NOISY SIGN.
SpO₂ NON-PULSAT.
SpO₂ ERRATIC
SpO₂ EXTD. UPDATE
SpO₂ LOW PERF |
୫ ୧
- 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.
87
- The new devices have the same technological characteristics as the legally marketed predicate devices.
88
- 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.
8 ਰੇ
90
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a stylized human face in profile.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2003
Mr. David Osborn Quality Program Manager Philips Medical Systems 3000 Minuteman Road Andover, Massachusetts 01810-1099
Re: K030973
Trade/Device Name: PICOSAT II SPO2 Pulse Oximetry Module Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA, DPZ Dated: July 15, 2003 Received: July 16, 2003
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 (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.
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.
3
Page 2 - Mr. 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 Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number (if known): K030973
Device Name: picoSAT II SpO2 pulse oximetry module
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.
signature
510(k) Number: K030973
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
21 CFR 801.109)
OR
Over-The-Counter (Per
(Optional Format 1-2-96)