(68 days)
Not Found
No
The device description and intended use are for blood pressure cuffs and air hoses, which are passive components for blood pressure measurement. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is described as being used for "non-invasive measurement of infant, pediatric, and adult human blood pressure," which is a diagnostic function rather than a therapeutic one.
Yes.
The device is intended for "non-invasive measurement of infant, pediatric, and adult human blood pressure," which is a diagnostic measurement.
No
The device description explicitly details physical components (cuffs, air hoses, tubing) made of materials like polyurethane coated polyester and PVC, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "non-invasive measurement of... human blood pressure." This is a physiological measurement taken directly from the patient's body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description details cuffs and air hoses used to connect to a blood pressure monitoring system. These are components for a non-invasive measurement device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a non-invasive medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
Philips multi-patient and single-patient cuffs are 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.
Philips air hoses are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the noninvasive measurement of neonatal, pediatric, and adult human blood pressure.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The Value Care Cuffs are a reusable single hose NBP cuff with a non-removable bladder. The Efficia Air hoses are standard tubing with compatible connector for the Value Care cuffs. The initial release encompasses six cuffs (Large Adult, Adult Long, Adult, Small Adult, Pediatric, Infant) and two air hoses (1.5 m and 3.0 m). They have color-coded tubings to differentiate them from other brands of cuffs and allow for quick cuff size identification. The patient contacting cuffs material is polyurethane coated polyester. The air hose tubing is made of PVC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infant (cuffs), pediatric (cuffs and hoses), adult (cuffs and hoses), neonatal (hoses)
Intended User / Care Setting
licensed physician or other healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject cuffs with subject air hoses demonstrated compliance with the requirements of the standards ANS/AAM//EC 80601-2-30 and ANSI/AAMI/EC 81060-1 as applicable to cuffs. The cuffs are for automated NBP devices. The performance testing completed demonstrates that the subject devices have level of safety and effectiveness as their predicate devices. The Value Care cuffs with Efficia air hoses demonstrate substantial equivalence as the Philips Easy Care family of cuffs cleared with K071885.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, with three curved lines above them, possibly representing the flow of information or services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Philips Medical Systems Ms. Mary Kruitwagen QA and Regulatory Affairs 3000 Minuteman Rd Andover, Massachusetts 03104-1099
Re: K152363
Trade/Device Name: Value Care Cuff Large Adult, Value Care Cuff Adult Xl (extra Long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: August 14, 2015 Received: August 20, 2015
Dear Ms. Mary Kruitwagen,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D.Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152363
Device Name
Value Care Cuff Large Adult, Value Care Cuff Adult, Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
Indications for Use (Describe)
Philips multi-patient and single-patient cuffs are 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.
Philips air hoses are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the noninvasive measurement of neonatal, pediatric, and adult human blood pressure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K152363
Page 1 of 3
Philips Value Care NBP Cuffs and Philips Efficia Air Hoses 510(k) Summary
| Prepared | September 18, 2015 | ||
|---|---|---|---|
| Submission Type: | Special 510(k) | ||
| Regulatory Information | |||
| Classification | Blood Pressure Cuff | ||
| Common/Usual name | Blood Pressure Cuff | ||
| Device trade name | Philips Value Care | ||
| Philips Efficia | |||
| Proprietary Name | Value Care Cuff Large Adult | ||
| Value Care Cuff Adult XL (extra long) | |||
| Value Care Cuff Adult | |||
| Value Care Cuff Small Adult | |||
| Value Care Cuff Pediatric | |||
| Value Care Cuff Infant | |||
| Efficia Adult NIBP Air Hose, 3 M | |||
| Efficia Adult NIBP Air Hose, 1.5 M | |||
| Model (same as reference number) | |||
| (respectively to the above models) | 989803160861 | ||
| 989803160851 | |||
| 989803160841 | |||
| 989803160831 | |||
| 989803160821 | |||
| 989803160811 | |||
| 989803160891 | |||
| 989803160881 | |||
| Device Sponsor | Philips Medical Systems, | ||
| 3000 Minuteman Rd, | |||
| Andover, MA, USA 01810-1099 | |||
| Device Owner | Philips Medical Systems, | ||
| 3000 Minuteman Rd, | |||
| Andover, MA, USA 01810-1099 | |||
| Establishment Registration number: | |||
| Sponsor/Manufacturer/ Owner/Operator: | 1218950 | ||
| 1217116 |
4
K152363 Page 2 of 3
| Contact | Mary Kruitwagen,
Philips Medical Systems,
3000 Minuteman Rd,
Andover, MA 01810-1099 USA
Email: mary.kruitwagen@philips.com
Phone: (978) 659-4932 / Fax: 978-659-7323 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternate contact | Peter Schipelliti,
Philips Medical Systems, 3000 Minuteman Rd,
Andover, MA 01810-1099 USA
Email: peter.schipelliti@philips.com
Phone: (978) 659-4744/ Fax: 978-659-7323 |
Device Classification:
The product code and individual classification monograph applicable to the subject devices is listed below
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| Cardiovascular | 870.1120, II | DXQ | Blood Pressure Cuff |
Predicate Device
| 510(k) | Date | Device | Owner/
Manufacturer | Trade
Name | Models |
|---------|------------|-----------------------------------------------------------------------|----------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| K071885 | 12/20/2007 | Philips Series of Multi-
Patient cuffs and
Single Patient Cuffs | Philips Medical
Systems | Easy
Care | M4552B, M4553B, M4554B, M4555B,
M4556B, M4557B, M4558B, M4559B,
M4562B, M4563B, M4564B, M4565B,
M4566B, M4567B, M4568B, M4569B |
Device Description
The Value Care Cuffs are a reusable single hose NBP cuff with a non-removable bladder. The Efficia Air hoses are standard tubing with compatible connector for the Value Care cuffs. The initial release encompasses six cuffs (Large Adult, Adult Long, Adult, Small Adult, Pediatric, Infant) and two air hoses (1.5 m and 3.0 m). They have color-coded tubings to differentiate them from other brands of cuffs and allow for quick cuff size identification. The patient contacting cuffs material is polyurethane coated polyester. The air hose tubing is made of PVC.
Fundamental Scientific Technology:
The design of the subject cuffs is similar to the predicate devices, with the integrated bladder, single hose, hook and loop closure. There are differences in material but testing of the subject devices demonstrates the same level of performance. The subject cuffs with subject air hoses demonstrated compliance with the requirements of the standards ANS/AAM//EC 80601-2-30 and ANSI/AAMI/EC 81060-1 as applicable to cuffs. The cuffs are for automated NBP devices. The fundamental scientific technology employed for the subject Value Care NBP Cuffs and Efficia Air Hoses is the same as the predicate NBP cuffs and air hoses.
The performance testing completed demonstrates that the subject devices have level of safety and effectiveness as their predicate devices. The Value Care cuffs with Efficia air hoses demonstrate substantial equivalence as the Philips Easy Care family of cuffs cleared with K071885.
Indications for Use
Philips multi-patient and single-patient cuffs are intended for use by, or under the supervision of, a licensed physician or
5
other healthcare provider for the non-invasive measurement of infant, pediatric, and adult human blood pressure.
Philips air hoses are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the noninvasive measurement of neonatal, pediatric, and adult human blood pressure.
Conclusion
The subject Value Care Cuffs with Efficia Air hoses demonstrate the same level of performance as the predicate devices as determined from the results of the performance testing. The results support that the subject devices should perform to the same level of safety as the predicate devices.