(68 days)
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.
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.
This document describes the Philips Value Care NBP Cuffs and Efficia Air Hoses. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the study proving direct adherence to those criteria for de novo approval.
However, based on the information provided, we can infer some details related to performance and testing:
Key Takeaways:
- Substantial Equivalence: The primary goal of this submission is to demonstrate that the Philips Value Care Cuffs and Efficia Air Hoses are substantially equivalent to the predicate device (Philips Easy Care family of cuffs cleared with K071885).
- Standards Compliance: The devices demonstrated compliance with the requirements of ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1 as applicable to cuffs. These standards inherently contain acceptance criteria for non-invasive blood pressure cuffs.
- Performance Testing: The submission states that "performance testing completed demonstrates that the subject devices have level of safety and effectiveness as their predicate devices." This implies that the testing was designed to show comparable performance to the predicate and compliance with relevant standards.
Given the nature of a 510(k) submission, specific numerical acceptance criteria (e.g., mean difference and standard deviation of blood pressure measurements) for these cuffs would typically be found within the details of the referenced standards (ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1). The document does not explicitly list these criteria in an accessible table format or provide detailed study results beyond the statement of compliance.
Therefore, the following answers are constructed based on the available information and reasonable inferences for a 510(k) submission concerning blood pressure cuffs. Many sections will note that specific details are "Not explicitly stated in the document" because the provided text is a summary focused on substantial equivalence rather than a full study report.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list a table of acceptance criteria and reported device performance directly. Instead, it states compliance with recognized standards.
Inferred/Expected Acceptance Criteria (based on ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1 for NIBP cuffs, though not explicitly listed in the document):
| Performance Metric | Acceptance Criteria (Typical for NIBP cuffs) | Reported Device Performance (as per document) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference (AI vs. Reference) ≤ 5 mmHg | "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." (Implies meeting the accuracy requirements within these standards.) |
| Standard Deviation (SD) | SD of differences (AI vs. Reference) ≤ 8 mmHg | Implied compliance with mentioned standards. |
| Pressure Loss/Leakage | Within specified limits (e.g., ≤ 10 mmHg/min) | Implied compliance with mentioned standards. |
| Cuff Durability/Fatigue | Withstand specified number of inflation/deflation cycles | "There are differences in material but testing of the subject devices demonstrates the same level of performance." (Implies comparable durability to predicate.) |
| Material Biocompatibility | Meet ISO 10993 requirements (or similar) | Not explicitly stated, but implied for device approval. |
| Alarm Functionality (if applicable) | Alarms activate correctly within specified thresholds | Not directly applicable for passive cuffs, but for connected NIBP monitors. |
| Physical Dimensions/Fit | Meet specified ranges for target patient populations | Variet of cuff sizes (Infant, Pediatric, Small Adult, Adult, Large Adult, Adult XL) indicates proper sizing. |
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 for Test Set: Not explicitly stated in the document.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The testing "demonstrates compliance" and "same level of performance" but does not detail the study design.
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)
- Number of Experts/Qualifications: Not applicable for blood pressure cuff accuracy testing. Ground truth for blood pressure is typically established using a reference measurement device (e.g., intra-arterial catheter or validated manometer) by trained technicians or clinicians. The document does not specify who conducted the measurements or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or specified. Blood pressure measurement accuracy studies typically involve direct comparisons to reference instruments rather than expert adjudication of interpretations.
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
- MRMC Study: Not applicable. This device is a blood pressure cuff and air hose, which are hardware components, not an AI-powered diagnostic tool requiring reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a passive component for non-invasive blood pressure measurement. Its performance is evaluated in conjunction with an NIBP monitor, but it is not an algorithm. The "performance testing" would evaluate the cuff's physical and functional integrity in facilitating accurate measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for blood pressure accuracy testing (implied by compliance with ANSI/AAMI standards) would typically be established by:
- Simultaneous, direct intra-arterial blood pressure measurements (considered the gold standard).
- Auscultatory measurements using a mercury manometer or another validated reference oscillometric device, performed by trained observers in a blinded fashion according to established protocols (e.g., AAMI/ISO 81060-2).
The document does not explicitly state the methodology for ground truth establishment, but it is implied by adherence to relevant standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a hardware component and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
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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
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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
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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) |
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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 InformationClassification | Blood Pressure Cuff | ||
| Common/Usual name | Blood Pressure Cuff | ||
| Device trade name | Philips Value CarePhilips Efficia | ||
| Proprietary Name | Value Care Cuff Large AdultValue Care Cuff Adult XL (extra long)Value Care Cuff AdultValue Care Cuff Small AdultValue Care Cuff PediatricValue Care Cuff InfantEfficia Adult NIBP Air Hose, 3 MEfficia Adult NIBP Air Hose, 1.5 M | ||
| Model (same as reference number)(respectively to the above models) | 989803160861989803160851989803160841989803160831989803160821989803160811989803160891989803160881 | ||
| 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: | 12189501217116 |
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K152363 Page 2 of 3
| Contact | Mary Kruitwagen,Philips Medical Systems,3000 Minuteman Rd,Andover, MA 01810-1099 USAEmail: mary.kruitwagen@philips.comPhone: (978) 659-4932 / Fax: 978-659-7323 |
|---|---|
| Alternate contact | Peter Schipelliti,Philips Medical Systems, 3000 Minuteman Rd,Andover, MA 01810-1099 USAEmail: peter.schipelliti@philips.comPhone: (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 | TradeName | Models |
|---|---|---|---|---|---|
| K071885 | 12/20/2007 | Philips Series of Multi-Patient cuffs andSingle Patient Cuffs | Philips MedicalSystems | EasyCare | 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
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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.
§ 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).