REPROCESSED MASIMO PULSE OXIMETER SENSORS

K081238 · Ascent Healthcare Solutions · NLF · Jul 29, 2008 · Cardiovascular

Device Facts

• Record ID: K081238
• Device Name: REPROCESSED MASIMO PULSE OXIMETER SENSORS
• Applicant: Ascent Healthcare Solutions
• Product Code: NLF · Cardiovascular
• Decision Date: Jul 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Reprocessed Pulse Oximeter Sensors are indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

Device Story

Reprocessed Low Noise Cabled Sensors (LNCS) for continuous noninvasive arterial oxygen saturation and pulse rate monitoring. Devices are adhesive sensors applied to patients; they function by transmitting light through tissue to detect arterial oxygen saturation and pulse rate. Reprocessing involves cleaning, decontamination, and functional testing of previously used sensors to restore them to original performance specifications. Used in clinical settings; operated by healthcare professionals. Output is provided to a compatible pulse oximeter monitor for clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of the reprocessing process, and functional testing of sensor components to ensure performance equivalent to the original devices.

Technological Characteristics

Reprocessed adhesive pulse oximeter sensors (LNCS series). Design, materials, and dimensions are identical to predicate devices. Sensing principle is optical (pulse oximetry). Reprocessing includes removal of visible soil and decontamination. No software or energy source changes; device is a passive sensor component.

Indications for Use

Indicated for continuous noninvasive arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and infant patient populations.

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

• LNCS and SPO2.COM Sensors (K060143)
• LNCS Oximetry Sensors (K041815)

Submission Summary (Full Text)

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JUL 2 9 2008

1081238

## SECTION 5: 510(k) SUMMARY

.

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Contact: | Katie Bray<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | April 29, 2008 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Pulse Oximeter Sensors | |
| | Classification Name: Oximeter, Reprocessed | |
| Predicate Device<br>K060143<br>K041815 | 510(k) Title<br>LNCS and SPO2.COM Sensors<br>LNCS Oximetry Sensors | Manufacturer<br>Masimo Corporation<br>Masimo Corporation |
| Device description: | The devices are reprocessed Low Noise Cabled Sensors<br>(LNCS)® Series - Adult, Pediatric, and Infant SpO2 adhesive<br>sensors. The sensors are disposable devices used for<br>continuous noninvasive arterial oxygen saturation and pulse rate<br>monitoring. | |
| Indications for Use: | Reprocessed Pulse Oximeter Sensors are indicated for use in<br>continuous noninvasive arterial oxygen saturation and pulse rate<br>monitoring. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed Pulse<br>Oximeter Sensors are identical to the predicate devices. The<br>mechanism of action of Reprocessed Pulse Oximeter Sensors is<br>identical to the predicate devices in that the same standard<br>mechanical design and size and equivalent materials are<br>utilized. There are no changes to the claims, intended use,<br>clinical applications, patient population, performance<br>specifications, or method of operation. In addition, Ascent<br>Healthcare Solutions' reprocessing of Pulse Oximeter Sensors<br>includes removal of adherent visible soil and decontamination.<br>Each individual Pulse Oximeter Sensor is tested for appropriate<br>function of its components prior to packaging and labeling<br>operations. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of Reprocessed Pulse<br>Oximeter Sensors. This included the following tests: | |

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- Biocompatibility
- . Validation of reprocessing
- . Function test(s)
- Packaging Validation .

Performance testing demonstrates that Reprocessed Pulse Oximeter Sensors perform as originally intended.

## Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Pulse Oximeter Sensors) are safe, effective, and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

JUL 29 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Bray Regulatory Affairs Manager Ascent Healthcare Solutions 10232 South 51st Street Phoenix, Arizona 85044

Re: K081238

Trade/Device Name: Reprocessed Masimo Pulse Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: April 29, 2008 Received: May 1, 2008

Dear Ms. Bray:

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.

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Page 2 - Ms. Bray

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

K. Kommelts-Lending for II

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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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Reprocessed Masimo Pulse Oximeter Sensors

## Indications For Use:

This sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

14081238 510(k) Number: ___

> Ascent Healthcare Solutions Reprocessed Pulse Oximeter Sensors Traditional 510(k)