ANTIMICROBIAL AND SINGLE-PATIENT CUFFS

K071885 · Philips Medical Systems · OED · Dec 20, 2007 · Cardiovascular

Device Facts

• Record ID: K071885
• Device Name: ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
• Applicant: Philips Medical Systems
• Product Code: OED · Cardiovascular
• Decision Date: Dec 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.

Device Story

Device consists of inelastic sleeve with integral inflatable bladder and tubing; wraps around patient limb; secured via hook and loop fastener. Tubing connects to NIBP measuring system. Used in clinical settings by healthcare providers to facilitate non-invasive blood pressure monitoring. Device functions as pneumatic interface for NIBP systems; enables pressure transmission to limb for oscillometric or auscultatory measurement. Benefits include reliable, non-invasive hemodynamic monitoring for diverse patient populations.

Clinical Evidence

Bench testing only. Performance and reliability validated via testing against ANSI/AAMI SP10:2002, EN 1060-1, EN 1060-3, IEC 60601-1, IEC 60601-2-30, and ISO 10993-1. All tests passed.

Technological Characteristics

Inelastic sleeve with integral inflatable bladder; hook and loop fastener; pneumatic tubing connection. Materials evaluated per ISO 10993-1. Complies with IEC 60601-1 and IEC 60601-2-30 safety standards for non-invasive blood pressure monitoring equipment.

Indications for Use

Indicated for non-invasive blood pressure measurement in infant, pediatric, and adult populations. For use by or under supervision of licensed healthcare providers.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• Reusable Non-invasive Blood Pressure Comfort Cuff (K001333)
• Disposable Non-invasive Blood Pressure Cuff (K901252)
• Reusable Non-invasive Blood Pressure Cuff (K884421)

Submission Summary (Full Text)

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# 71888 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Philips series of Multi-Patient Cuffs and Single-Patient Cuffs

#### Submitter's Name and Address

| Submitter's Name: | Philips Medical Systems |
|-----------------------|---------------------------------|
| Division: | Medical Consumables and Sensors |
| Address: | 3000 Minuteman Road |
| City, State, and Zip: | Andover, MA, 01810 |

#### Contact Person

| Name: | Peter Schipelliti |
|------------|-------------------------------|
| Title: | Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

#### Date of Summary

Date:

December 11, 2007

#### Manufacturing Facility Address

| Manufacturer: | Philips Medical Systems |
|-----------------------|-------------------------|
| Address: | 3000 Minuteman Road |
| City, State, and ZIP: | Andover, MA, 01810 |

#### Establishment Registration Number

Est. Registration Number: 1218950

#### New Device Details

#### Proprietary of Trade Names

Proprietary or Trade Name:

Philips series of Multi-Patient Cuffs and Single-Patient Cuffs

#### New Device Common Name

Common Name:

Blood Pressure Cuff

Philips Medical Systems APPENDIX E Philips series of Multi-Patient Cuffs and Single-Patient Cuffs 510(k)

December 11, 2007 Page 1 of 3

2007

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#### New Device Class

| Device Class: | Class II |
|---------------------------------|----------------------|
| New Device Product Code | |
| Device Procode: | DXQ |
| New Device CFR | |
| Device CFR: | 870.1120 |
| New Device Classification Panel | |
| Classification Panel: | Cardiovascular |
| New Device Classification Name | |
| Classification Name: | Cuff, Blood Pressure |
| Reason for submission · | |
| Reason for submission | Modified Devices |

#### Predicates

| Predicate #1 | (K001333) Reusable Non-invasive Blood Pressure Comfort<br>Cuff |
|--------------|----------------------------------------------------------------|
| Predicate #2 | (K901252) Disposable Non-invasive Blood Pressure Cuff |
| Predicate #3 | (K884421) Reusable Non-invasive Blood Pressure Cuff |

#### Comparison of Technological Characteristics

The modified devices have the same technological characteristics as the legally marketed predicate devices. Safety characteristics are unchanged by these modifications

#### Summary of Intended Uses

Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.

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#### Description of Device

The device comprises tubing attached to an inelastic sleeve with an integral inflatable bladder that is wrapped around a patient's limb. It is secured by a hook and loop fastener. Device tubing is attached to an NIBP measuring system.

#### Device Testing

Device testing was performed according to the Validation Traceability Matrix. These activities were conducted to establish the performance and reliability characteristics of the modified devices. All tests passed.

#### Voluntary Standards Used in Determination of Substantial Equivalence:

The cuffs were tested according to:

- ANSI/AAMI SP10:2002 +A1:2003 "Manual, electronic, or automated . sphygmomanometers"
- EN 1060-1:1995 +A1:2002; "Non-invasive sphygmomanometers Part 1: . General Requirements"
- EN 1060-3:1997 +A1:2005; "Non-invasive sphygmomanometers Part 3: . Supplementary requirements for electro-mechanical blood pressure measuring systems"
- IEC 60601-1:1988 +A1:1991 +A2:1995; "Medical Electrical Equipment → . Part 1: General Requirements for Safety"
- . IEC 60601-2-30:1999; "Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment"
- ISO 10993-1:2003; "Biological evaluation of medical devices Part 1: . Evaluation and Testing"

All tests passed and therefore it is concluded that the product is safe and effective.

#### Conclusion

Based on similarity in technology, characteristics and the same intended use as the predicates, these devices are substantially equivalent.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEC 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Peter Schipelliti Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810-1099

#### Re: K071885

Trade/Device Name: Multi-Patient Cuffs, Models M4552B, M4553B, M4554B, M4555B, M4556B, M4557B, M4558B, M4559B, M4562B, M4563B, M4564B, M4565B, M4566B, M4567B, M4568B, and M4569B (16 Models); and Single-Patient Cuffs, Models M4572B, M4573B, M4573B, M4574B, M4575B, M4576B, M4577B, M4578B, M4579B, M4582B, M4583B, M4584B, M4585B, M4586B, M4587B, M4588B, and, M4589B (16 Models) Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: OED Dated: November 21, 2007 Received: November 23, 2007

Dear Mr. Schipelliti:

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.

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#### Page 2 - Mr. Peter Schipelliti

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. 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 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.

B. Zimmerman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PHILIPS

510(k) Number_K071885

Device Name: Philips series of Multi-Patient Cuffs and Single-Patient Cuffs

Indications For Use:

Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.

| Prescription Use (21 CFR 801 Subpart D) | X |
|---------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| | Bhimmerma |
|---------------|------------------------------------|
| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| 510(k) Number | K071885 |

Philips Medical Systems Philips Series of Multi-Patient Cuffs and Single-Patient Cuffs 510(k)

December 11, 2007 Page xv of xviii