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 Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for Philips Multi-Patient and Single-Patient Cuffs. This document primarily focuses on establishing substantial equivalence to predicate devices and adherence to recognized standards for medical device safety and performance. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving device performance in the context of AI studies.

Here's a breakdown of what can be extracted and what information is missing based on your template:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document lists several voluntary standards the cuffs were tested against (e.g., ANSI/AAMI SP10:2002 +A1:2003, EN 1060-1:1995 +A1:2002, IEC 60601-1:1988). The acceptance criteria are implicitly the requirements outlined in these standards for blood pressure cuffs.
Reported Device Performance: The document states, "All tests passed." However, it does not provide specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) against these standards. It only indicates compliance.

Acceptance Criteria (Implicit from Standards)	Reported Device Performance
ANSI/AAMI SP10:2002 +A1:2003	Passed
EN 1060-1:1995 +A1:2002	Passed
EN 1060-3:1997 +A1:2005	Passed
IEC 60601-1:1988 +A1:1991 +A2:1995	Passed
IEC 60601-2-30:1999	Passed
ISO 10993-1:2003	Passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified. The document only mentions "Device testing was performed according to the Validation Traceability Matrix."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This document is for a blood pressure cuff, not an AI-driven diagnostic device that would typically rely on expert-established ground truth in this manner. The "ground truth" for a physical device like a blood pressure cuff is its adherence to metrological and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This document is for a physical medical device (blood pressure cuff), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. It's a blood pressure cuff and requires connection to an NIBP measuring system for use by a healthcare provider.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for these physical cuffs is their compliance with established medical device standards for non-invasive blood pressure measurement devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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:	(978) 687-1501
Facsimile:	(978) 659-7712
E-mail:	Peter.schipelliti@philips.com

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 ComfortCuff
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

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Description of Device

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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)
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	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

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
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.(b)
Classification. Class II (performance standards).