H100B PULSE OXIMETER

K092727 · Edan Instruments, Inc. · DQA · Dec 3, 2009 · Cardiovascular

Device Facts

• Record ID: K092727
• Device Name: H100B PULSE OXIMETER
• Applicant: Edan Instruments, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Dec 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Device Story

H100B Pulse Oximeter is a portable device for continuous or spot-check monitoring of SpO2 and pulse rate. Input: optical signals from a finger sensor. Processing: main unit converts sensor signals into electronic data; calculates SpO2 and pulse rate. Output: LCD display showing numerical values, plethysmogram, bar graph, and waveform. Usage: hospitals, intra-hospital transport, and hospital-type facilities; operated by clinicians. Data management software (Oximeter Viewer) allows transfer of stored data to a PC for review and printing. Device powered by AA batteries (alkaline or Ni-H rechargeable). Includes audio and visual alarms for limit violations or technical issues. Benefits: provides real-time physiological monitoring to assist clinical decision-making regarding patient oxygenation status.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including software testing, safety testing, risk analysis, and final validation.

Technological Characteristics

Portable pulse oximeter; powered by 4x 1.5V AA or 1.2V Ni-H rechargeable batteries. Features LCD display for numerical and waveform data. Includes data management software for PC connectivity. Provides audio/visual alarms. Sterilization method not specified. Software-based signal processing for SpO2 and pulse rate calculation.

Indications for Use

Indicated for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate in adult, pediatric, and neonate patients in hospital settings, including intra-hospital transport.

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

• PM 60 Pulse Oximeter (K072581)

Submission Summary (Full Text)

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K092727)

#### DEC -- 3 2009 H100B Pulse Oximeter 510(k) Submission Section 1

# 510 (K) Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

- Submitter: Edan Instruments, Inc 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China Tel: [phone] Fax:[phone] Contact person: Jiang Yucai
- Official correspondent: _ William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: [phone] X27 Fax: [phone]
- H100B Pulse Oximeter Proprietary Name:
- Classification Name: _ 21 CFR 870.2700 Oximeter

DQA Product code:

Classification: Class II

Predicate Devices: PM 60 Pulse Oximeter K072581 Shenzhen Mindray Bio-medical Electronics Co., LTD

Device Description: H100B Pulse Oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities. The sampled signal from finger sensor is processed in the main unit and transferred into electronic signal to display the SpO2 value, pulse rate value on the LCD at the form of numeral, plethysmogram, bar graph and waveform. Data management software (Oximeter Viewer) can transferred stored data into PC for storage, review and printing.

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### H100B Pulse Oximeter 510(k) Submission Section 1

The subject device is powered by 4 pieces 1.5V AA batteries or 4 pieces 1.2V Ni-H rechargeable AA batteries. Alarm capability including audio alarm and indicator is provided when the SpO2 value is lower than the limit setup or some technical reason.

#### Comparison with predicate device

| | Subject device | Predicated device |
|-----------------------------|----------------------|---------------------|
| Monitoring functions | H100B Pulse Oximeter | PM60 Pulse Oximeter |
| SpO2 | yes | yes |
| Pulse Rate | yes | yes |
| Alarm feature | yes | yes |
| Data management<br>software | yes | yes |

Intended Use: The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Test Summary: The following quality assurance measures were applied to the development of the H100B Pulse Oximeter:

- · Software testing
- Safety testing
- Risk analysis
- Final validation

Conclusion: Verification and validation testing was done on the H100B Pulse Oximeter. This premarket notification submission demonstrates that H100B Pulse Oximeter is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, rendered in a simple, graphic style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC - 8 2009

Edan Instruments, Incorporated C/O Mr. Li Fu Consultant Shanghai MidLink Business Consulting Company, Limited Suite 8D, No. 19, Lane 999, Zhongshan Road (S-2) Shanghai, 200030, China

Re: K092727

Trade/Device Name: H100B Pulse Oximeter Regulation Number: 21CFR 870.2700 ·Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 31, 2009 Received: September 4, 2009

Dear Mr. Fu:

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 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- Mr. Fu

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division 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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### H100B Pulse Oximeter 510(k) Submission Section 1

# Indication for Use

510(k) Number (if known):

H100B Pulse Oximeter Device Name:

The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

Prescription Use (21 CFR Part 801 Subpart D) Or Over the Counter Use _ (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

(Division Sign-Off) · vision of Anesthesiology, General Hospital nection Control, Dental Devices

-10(k) Number: K692727