PULSE OXIMETER ADAPTER CABLES

K052544 · American I.V. Products, Inc. · DQA · Sep 29, 2006 · Cardiovascular

Device Facts

• Record ID: K052544
• Device Name: PULSE OXIMETER ADAPTER CABLES
• Applicant: American I.V. Products, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

Device Story

Pulse oximeter adapter cables; passive electrical interface between OEM pulse oximeter sensors and OEM patient monitors. Cables transmit raw sensor signals to monitor for processing; no active signal processing or data analysis performed by cable. Used in clinical and home environments; operated by healthcare professionals or patients. Facilitates continuous SpO2 and pulse rate monitoring; enables clinical decision-making based on monitor-generated data. Reusable; non-sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through electrical, mechanical, and safety testing, including conformity to IEC 60601-1 and IEC 60601-1-2 standards to demonstrate equivalence to OEM cables.

Technological Characteristics

Flexible, shielded, multi-conductor electrical cable. Keyed connectors for specific OEM monitor compatibility. Non-sterile. Passive electrical transmission; no active sensing or energy source. Complies with IEC 60601-1 (Safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients, well or poorly perfused, requiring continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in hospital, intra-hospital transport, or home settings.

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

• Criticare Model 518DD (K001020)
• Corometrics Model 4033CAX (K934959)
• Datascope Model 0012-00-0516-02 (K97006, K993531)
• GE Medical Systems Model E9004GE (K012467, K033304)
• GE Medical Systems Model 2006644-001 (K012467, K033304)
• Nellcor MC10 (K991823, K993637, K973147)
• Nellcor DEC8 (K971946)
• Nellcor SCP10 (K991823, K993637, K973147)
• Phillips Model M1940A (K014159)
• Phillips Model M1941A (K993383)
• Phillips Model M1943A (K021453)
• Spacelabs Model 700-0002-00 (K901209)
• Spacelabs Model 700-0030-00 (K972502)
• Spacelabs Model 175-0646-00 (K901209)
• Spacelabs Model 700-0029-00 (K972502)

Submission Summary (Full Text)

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K052544

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Supporting Clinical Engineering Worldwide

SEP 2 9 2006

Appendix C Page 1 of 2

510(k) Summarv

## Submitter Information:

American IV Products, Inc. 7485 Shipley Avenue Hanover, MD 21076

### Contact:

Gregory Falk Director of Regulatory Affairs and Quality Assurance Telephone: [phone] ext. 129 Fax: [phone] e-mail: [e-mail]

### Date Prepared:

September 15, 2005

#### Product Name:

Classification Name: Pulse Oximeter Adapter Cables Common Name: Pulse Oximeter Adapter Cables Proprietary Name: Pulse Oximeter Adapter Cables

## Predicate Device:

These AIV devices are equivalent to the following legally marketed devices:

Criticare Model: 518DD - K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 0012-00-0516-02 - K97006 & K993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Nellcor: MC10 - K991823, K993637 & K973147 Nellcor: DEC8 - K971946 Nellcor: SCP10 - K991823, K993637 & K973147 Phillips Model: M1940A - K014159 Phillips Model: M1941A - K993383 Phillips Model: M1943A - K021453 Spacelabs Model: 700-0002-00 - K901209 Spacelabs Model: 700-0030-00 - K972502 Spacelabs Model: 175-0646-00 - K901209 Spacelabs Model: 700-0029-00 - K972502

#### Description:

AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM).

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The OEM monitors are used for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

## Intended Use:

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospital type facilities, intra-hospital transport and home environments.

# Comparison to Predicate Device:

| | AIV | OEM |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. | Same |
| Type of Construction | Flexible, shielded, multi conductor electrical cable. | Same |
| Connector Design | Adapter cable connectors are keyed to fit the appropriate monitors. | Same |
| Installation into system | Installed in system between monitor and sensor using keyed connectors. | Same |
| Target Patient Population | Patients that are well or poorly perfused. | Same |
| Patient Use/Reuse | Reusable. | Same |
| Sterility | Non-sterile. | Same |
| IEC 60601-1 Testing | Passed Safety Testing. | Same |
| IEC 60601-1-2 Testing | Passed or when OEM system not passing with AIV cable, then OEM system tested with OEM adapter cable to show AIV equivalent to OEM adapter cable. | Same |

## Performance Data and Conclusions:

- . AIV design is equivalent to predicate device design.
- Bench Testing demonstrates that the AIV devices perform as intended. .
- . The company has declared conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety
- . These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2006

Mr. Gregory Falk Director of Regulatory Affairs and Quality Assurance American I.V. Products. Incorporated 7485 Shipley Avenue Hanover, Maryland 21076

Re: K052544

Trade/Device Name: Pulse Oximeter Adapter Cables Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 5, 2006 Received: September 6, 2006

Dear Mr. Falk:

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 - Mr. Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 Acti: 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 vour 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/industry/support/index.html.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): Page 1 of

Device Name: Pulse Oximeter Adapter Cables

Indications For Use:

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

| AIV Part # | OEM Part # | OEM Monitor use |
|------------|------------------------|------------------------------------------------------------------------------------------------------------------------|
| CBCSI | 518DD | Criticare 504DX, 506DX & Alaris 8100 |
| CBCORO | 4033CAX | Corometrics 118 and Fetal Center Monitor |
| CBDAT | 0012-00-0516-02 | Datascope Passport, Accutor Plus, Sat 3 & Sat 4 |
| CB10640 | E9004GE<br>2006644-001 | GE Medical Systems Solar 8000M & 9500M, Solar Tram<br>Modules T451N & T851N, Dash 2000, 3000 & 4000 |
| CB10587 | MC10 | Nellcor NPB-290, NPB-295 & N-395 |
| CB10588 | DEC8 | Nellcor N-20, NPB-40, NPB-75, NPB-190<br>Welch Allyn Protocol Propaq<br>Most BCI Monitors |
| CB10641 | SCP10 | Nellcor NPB-290, NPB-295, N395 & N-3000 |
| CBHPHP1 | M1940A | Philips M1175A, M1176A, 78352A, 78352C, 78354A,<br>78354C, 7833A, M78833B, M1722A, M1722B, M1723A,<br>M1723B, & M2475B |
| CB10586 | M1941A | Philips M3000A Viridia, M3500B Heartstream XLT<br>Defib/Monitor & M4735A XL Defib/Monitor |
| CB10590 | M1943A | Philips M2601A Viridia, M3000A Viridia, M3500B<br>Heartstream XLT Defib/Monitor & M4735A XL<br>Defib/Monitor |
| CBSP1 | 700-0002-00 | Spacelabs Monitors with modules: 90351-D/G,<br>90465/66/67, 90489, 90651-A & 90651-08 |
| CBSP2 | 700-0030-00 | Spacelabs Ultraview 1050, 1600, 1700 & all monitors<br>using Ultraview Command Module 90496 |

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# Appendix B Page 2 of 2

Page 2 of _ 2__

| CBSPNV1 | 175-0646-00 | Spacelabs Monitors with modules: 90351-D/G,<br>90465/66/67, 90489 90651-A & 90651-08 |
|---------|-------------|---------------------------------------------------------------------------------------------|
| CBSPNV2 | 700-0029-00 | Spacelabs Ultraview 1050, 1600, 1700 & all monitors<br>using Ultraview Command Module 90496 |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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