(117 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.
The picoSAT II SpO2 pulse oximetry module for use in host patient monitors.
The Philips Medical Systems picoSAT II SpO2 pulse oximetry module (K030973) is intended for monitoring, recording, and alarming of multiple physiological parameters (SpO2 and pulse rate) in adults, pediatrics, and neonates within hospital and patient transport environments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Specification) | Reported Device Performance (Provided as Specification) |
|---|---|---|
| SpO2 Accuracy (functional) over range of 70% to 100% for neonates through adults (reusable probes) | Not explicitly stated as "acceptance criteria", but implied by device specification. | M1191A and M1192A: ± 2.5% |
| M1193A and M1195A: ± 3.0% | ||
| M1194A: ± 3.0% (adult only) | ||
| SpO2 Accuracy (functional) over range of 70% to 100% for adults and neonates (disposable probes) | Not explicitly stated as "acceptance criteria", but implied by device specification. | M190xA and Nellcor®: ±3.0% |
| Perfusion Indicator | >0.3 indicates that >95% of the time signals are good enough for valid measurements. At 0, no measurement is made. | An indicator of SpO₂ signal quality>0.3 indicates that >95% of the timesignals are good enough for validmeasurements.At 0, no measurement is made. (This is a description, and implies the device meets this rule.) |
| 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. | SpO₂ and pulse rate parameter output and theSpO₂ Non-pulsatile and Pleth Non-pulsatileINOPS are suppressed for adjustable periodof 30 s to 60 s when picoSAT II SpO2 pulseoximetry module detects that an NBPmeasurement is in progress. SpO2 EXTD.UPDATE INOP generated after 30 s ofsuppression. (This is a description, and implies the device meets this rule.) |
| Technical alarm conditions (INOPS) | Generates various specified technical alarm conditions (SpO₂ EQUIP MALF, SpO₂ TEST SIGNAL, etc.). | Generates the following technical alarmconditions:SpO₂ EQUIP MALFSpO₂ TEST SIGNALSpO₂ SENSOR MALFNO SpO₂ SENSORSpO₂ INTERFERENCESpO₂ LEARNINGSpO₂ NOISY SIGN.SpO₂ NON-PULSAT.SpO₂ ERRATICSpO₂ EXTD. UPDATESpO₂ LOW PERF (This means it is designed to achieve this.) |
| SpO2 Algorithm | Philips FAST SpO2 algorithm motion and low perfusion tolerant (Implied by specification) | Philips FAST SpO2 algorithmmotion and low perfusion tolerant |
| SpO2 displayed range | 0% to 100% (Implied by specification) | 0% to 100% |
| SpO2 parameter resolution | 1% (Implied by specification) | 1% |
| Pulse Rate parameter range & resolution | 30 bpm to 300 bpm ±2% or 1 bpm whichever is greater (Implied by specification) | 30 bpm to 300 bpm ±2% or 1 bpm whichever isgreater |
| FAST SpO2 parameter averaging | 5 s to 20 s (Implied by specification) | 5 s to 20 s |
| SpO2 parameter data update period | 1 s (Implied by specification) | 1 s |
| Pleth wave height requirement | 32 pixels, minimum (Implied by specification) | 32 pixels, minimum |
| Input power | 1.8 V to 11.5 Vdc, 300 mW max (Implied by specification) | 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 (Implied by specification) | 3/5 V logic levels, switchable'8-bit word with stop, start & parity bit |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical validation studies were also conducted," but does not provide any specific sample sizes for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. The document focuses on the technical specifications and clinical validation of the device itself, not a comparison of human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation of the algorithm is implied. The document states "Clinical validation studies were also conducted" in the context of establishing the performance characteristics of the new device (the picoSAT II module, which includes the Philips FAST SpO2 algorithm). The specifications for SpO2 accuracy (e.g., ± 2.5%, ± 3.0%) are direct measurements of the device's ability to accurately determine SpO2 levels.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical validation studies is not explicitly stated, but for SpO2 accuracy measurements, it is conventionally established through co-oximetry readings of arterial blood samples, which is considered the gold standard for blood oxygen saturation. While not explicitly mentioned, this is the expected method for establishing ground truth in pulse oximetry validation studies.
8. The Sample Size for the Training Set
This information is not provided in the document. The document refers to "Philips FAST SpO2 algorithm," implying a pre-existing or internal development and training process, but details are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Similar to the test set, it would likely involve co-oximetry readings of arterial blood samples if applicable to the algorithm's development.
{0}------------------------------------------------
KO309B
JUL 2 8 2003
| 8.0 510(k) Summary | |||
|---|---|---|---|
| This summary of 510(k) safety and effectiveness information issubmitted in accordance with the requirements of the Safe MedicalDevices 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 oximetrymodule. Classification names are as follows: | |||
| Device Panel | Classification | ProCode | Description |
| Anesthesiologyand RespiratoryTherapy (12624) | §870.2700, II | DQA | Oximeter |
| 3. The new device is substantially equivalent to previously clearedPhilips devices M3000A & M3001A marketed pursuant to K971910, K990972,K000822, K013199, and K021300. | |||
| 4. The modification creates the picoSAT II SpO2 pulse oximetry module foruse in host patient monitors. | |||
| 5. picoSAT II SpO2 pulse oximetry module specifications. | |||
| Item | Specification | ||
| SpO2 Algorithm | Philips FAST SpO2 algorithmmotion and low perfusion tolerant | ||
| SpO2 displayed range | 0% to 100% | ||
| SpO2 accuracy (functional) overthe range of 70% to 100% forneonates through adults(reusable probes) | M1191A and M1192A: ± 2.5%M1193A and M1195A: ± 3.0%M1194A: ± 3.0% (adult only) | ||
| SpO2 accuracy (functional) overthe range of 70% to 100% foradults 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 isgreater | ||
| FAST SpO2 parameter averaging | 5 s to 20 s | ||
| SpO2 parameter data updateperiod | 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 timesignals are good enough for validmeasurements.At 0, no measurement is made. |
| NBP cuff inflation detectionsuppression of SpO2 INOPs ¶meter output | SpO₂ and pulse rate parameter output and theSpO₂ Non-pulsatile and Pleth Non-pulsatileINOPS are suppressed for adjustable periodof 30 s to 60 s when picoSAT II SpO2 pulseoximetry module detects that an NBPmeasurement is in progress. SpO2 EXTD.UPDATE INOP generated after 30 s ofsuppression. |
| Technical alarm conditions(INOPS) | Generates the following technical alarmconditions:SpO₂ EQUIP MALFSpO₂ TEST SIGNALSpO₂ SENSOR MALFNO SpO₂ SENSORSpO₂ INTERFERENCESpO₂ LEARNINGSpO₂ NOISY SIGN.SpO₂ NON-PULSAT.SpO₂ ERRATICSpO₂ EXTD. UPDATESpO₂ 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)
§ 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).