PICOSAT II SPO2 PULSE OXIMETRY MODULE

K030973 · Philips Medical Systems · DQA · Jul 23, 2003 · Cardiovascular

Device Facts

• Record ID: K030973
• Device Name: PICOSAT II SPO2 PULSE OXIMETRY MODULE
• Applicant: Philips Medical Systems
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

picoSAT II SpO2 pulse oximetry module integrates into host patient monitors to provide continuous SpO2 and pulse rate monitoring. Device processes optical signals from reusable or disposable probes to calculate oxygen saturation and pulse rate; utilizes Philips FAST SpO2 algorithm for motion and low perfusion tolerance. Output includes SpO2 values, pulse rate, plethysmographic waveforms, and technical alarm conditions (INOPS). Used in hospital and transport environments by healthcare professionals. Module features NBP cuff inflation detection to suppress INOPs during measurements. Data is transmitted via serial interface to host monitor for display and clinical decision-making. Benefits include reliable patient monitoring during motion or low perfusion states.

Clinical Evidence

Clinical validation studies were conducted to confirm performance. Testing included functional level tests and safety testing based on risk analysis. Accuracy was verified across neonate through adult populations using both reusable and disposable probes, with functional accuracy ranging from ±2.5% to ±3.0% for SpO2 and ±2% or 1 bpm for pulse rate.

Technological Characteristics

Module for host patient monitors; utilizes Philips FAST SpO2 algorithm. SpO2 range 0-100%; pulse rate 30-300 bpm. Serial data interface (3/5 V logic). Power input 1.8-11.5 Vdc. Features perfusion indicator and NBP cuff inflation suppression logic. Supports reusable and disposable probes.

Indications for Use

Indicated for monitoring, recording, and alarming of physiological parameters in adult, pediatric, and neonatal patients in hospital and transport settings by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Philips M3000A (K971910, K990972, K000822, K013199, K021300)
• Philips M3001A (K971910, K990972, K000822, K013199, K021300)

Submission Summary (Full Text)

{0}------------------------------------------------

## KO309B

JUL 2 8 2003

| 8.0 510(k) Summary | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------|-------------|
| This summary of 510(k) safety and effectiveness information is<br>submitted in accordance with the requirements of the Safe Medical<br>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: [phone] | Fax: [phone] | |
| | e-mail: [e-mail] | | |
| This summary was prepared on July 15, 2003. | | | |
| 2. The name of the device is the picoSAT II SpO2 pulse oximetry<br>module. Classification names are as follows: | | | |
| Device Panel | Classification | ProCode | Description |
| Anesthesiology<br>and Respiratory<br>Therapy (12624) | §870.2700, II | DQA | Oximeter |
| 3. The new device is substantially equivalent to previously cleared<br>Philips devices M3000A & M3001A marketed pursuant to K971910, K990972,<br>K000822, K013199, and K021300. | | | |
| 4. The modification creates the picoSAT II SpO2 pulse oximetry module for<br>use in host patient monitors. | | | |
| 5. picoSAT II SpO2 pulse oximetry module specifications. | | | |
| Item | Specification | | |
| SpO2 Algorithm | Philips FAST SpO2 algorithm<br>motion and low perfusion tolerant | | |
| SpO2 displayed range | 0% to 100% | | |
| SpO2 accuracy (functional) over<br>the range of 70% to 100% for<br>neonates through adults<br>(reusable probes) | M1191A and M1192A: ± 2.5%<br>M1193A and M1195A: ± 3.0%<br>M1194A: ± 3.0% (adult only) | | |
| SpO2 accuracy (functional) over<br>the range of 70% to 100% for<br>adults and neonates<br>(disposable probes) | M190xA and Nellcor®: ±3.0% | | |
| SpO2 parameter resolution | 1% | | |
| Pulse Rate parameter range &<br>resolution | 30 bpm to 300 bpm ±2% or 1 bpm whichever is<br>greater | | |
| FAST SpO2 parameter averaging | 5 s to 20 s | | |
| SpO2 parameter data update<br>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<br>>0.3 indicates that >95% of the time<br>signals are good enough for valid<br>measurements.<br>At 0, no measurement is made. |
| NBP cuff inflation detection<br>suppression of SpO2 INOPs &<br>parameter output | SpO₂ and pulse rate parameter output and the<br>SpO₂ Non-pulsatile and Pleth Non-pulsatile<br>INOPS are suppressed for adjustable period<br>of 30 s to 60 s when picoSAT II SpO2 pulse<br>oximetry module detects that an NBP<br>measurement is in progress. SpO2 EXTD.<br>UPDATE INOP generated after 30 s of<br>suppression. |
| Technical alarm conditions<br>(INOPS) | Generates the following technical alarm<br>conditions:<br>SpO₂ EQUIP MALF<br>SpO₂ TEST SIGNAL<br>SpO₂ SENSOR MALF<br>NO SpO₂ SENSOR<br>SpO₂ INTERFERENCE<br>SpO₂ LEARNING<br>SpO₂ NOISY SIGN.<br>SpO₂ NON-PULSAT.<br>SpO₂ ERRATIC<br>SpO₂ EXTD. UPDATE<br>SpO₂ LOW PERF |

୫ ୧

6. 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

7. The new devices have the same technological characteristics as the legally marketed predicate devices.

88

8. 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 [phone]. 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 [phone] or [phone] 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)