(154 days)
Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.
The provided text describes a 510(k) submission for a blood pressure cuff and references some testing, but does not contain the detailed study information typically required to directly answer all parts of your request.
Specifically, it lacks:
- Explicit "acceptance criteria" for performance that are separate from the testing standards.
- "Reported device performance" in terms of specific metrics like accuracy, bias, or precision of blood pressure measurement.
- Details about a "test set" in the context of AI/algorithm performance (which is not applicable here as this is a physical device).
- Information on "experts" or "ground truth" establishment, as this is a physical measurement device, not an image analysis or diagnostic algorithm.
- Any mention of "multi reader multi case (MRMC) comparative effectiveness study" or "standalone (algorithm only)" performance, as these are related to AI/software.
- Sample sizes for training sets (again, not applicable to this type of device).
The document focuses on substantial equivalence to predicate devices and adherence to recognized standards for physical devices.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with specific performance metrics (e.g., mean difference in mmHg). Instead, it states that the device was tested per AAMI SP10:2002+A1:2003+A2:2006. For blood pressure cuffs, AAMI SP10 is the recognized standard for performance requirements and testing. Compliance with this standard implies that the device meets the performance specifications outlined within it (e.g., accuracy, pressure stability, deflation rates, etc.).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with AAMI SP10:2002+A1:2003+A2:2006 | Device was tested per AAMI SP10:2002+A1:2003+A2:2006, implying compliance. |
| Compliance with ISO 10993 series standards (Biocompatibility) | Device was tested per ISO 10993 series standards, implying compliance. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/algorithm test set. For a physical blood pressure cuff, testing typically involves a number of samples of the cuff itself and a number of human subjects for clinical validation studies if required, but these details are not provided in this summary. The summary only states "The device was tested per... AAMI SP10." The data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device intended for measurement, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable to this type of device or study described.
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
Not applicable. This is a physical device, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used
For a blood pressure cuff, "ground truth" for blood pressure accuracy is typically established by comparing the device's readings against a reference standard method (e.g., intra-arterial measurement, auscultatory method by trained observers with mercury sphygmomanometer) as specified by standards like AAMI SP10. The document does not specify the exact method used for establishing the ground truth beyond stating compliance with AAMI SP10.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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| Attachment II 510(k) Summary | ||||
|---|---|---|---|---|
| A required by 21 CFR 807.92 | ||||
| The assigned 510(k) number is: _ K102825 | ||||
| Date of Preparation | September 28, 2010 | |||
| 510(k) Sponsor | APK Technology Co., Ltd, Registration #: 3007699081 | |||
| 504, C6 Building, Hengfeng Industry, Hezhou, | ||||
| Xixiang, Baoan District, Shenzhen, Guangdong, 518126, China | ||||
| Contact Person: Cindy Chan | ||||
| Tel: 86-755-27325581 | ||||
| Fax: 86-755-27325585 | ||||
| Email: cindy@apk-technology.com | ||||
| Submission | Mr. Lee Fu | |||
| Correspondent | Mid-Link Consulting Co., Ltd | |||
| P.O. BOX 237-023, Shanghai, 200237, China | ||||
| T: +86-21-22815850 F: 240-238-7587 | ||||
| Proposed Device | Device Trade Name: Blood Pressure Cuff; | |||
| Classification: Class II DXQ 21 CFR 870.1120; | ||||
| Intended Use | Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped | |||
| on the upper arm and used with a non-invasive blood pressure monitor system to | ||||
| determine blood parameters on neonate, pediatric and adult patients. |
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Additional Information I for K102825 Blood Pressure Cuff -Attachment II 510(k) Summary
Device Description
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.
| Model | Intended Arm Range (Unit: cm) | Disposable | Reusable |
|---|---|---|---|
| A-XT-12D(1) | 3.3-5.6 | X | |
| A-XT-12D(2) | 4.2-7.1 | X | |
| A-XT-12D(3) | 5-10.5 | X | |
| A-XT-12D(4) | 6.9-11.7 | X | |
| A-XT-12D(5) | 8.9-15 | X | |
| A-XT-12D(7) | 9.8-13.3 | X | |
| A-XT-09D(8) | 12.4-16.8 | X | |
| A-XT-08D(9) | 15.8-21.3 | X | |
| A-XT-08D(10) | 20-27 | X | |
| A-XT-07D(11) | 25.3-34.3 | X | |
| A-XT-10D(12) | 32.1-43.4 | X | |
| A-XT-11D(13) | 44-66 | X | |
| A-XT-07 | 25-35 | X | |
| A-XT-08 | 18-26 | X | |
| A-XT-09 | 10-19 | X | |
| A-XT-10 | 33-47 | X | |
| A-XT-11 | 44-66 | X | |
| A-XT-12 | 6-11 | X | |
| A-XT-12W(1) | 3.3-5.6 | X | |
| A-XT-12W(2) | 4.2-7.1 | X | |
| A-XT-12W(3) | 5-10.5 | X | |
| A-XT-12W(4) | 6.9-11.7 | X | |
| A-XT-12W(5) | 8.9-15 | X | |
| A-XT-12W(7) | 9.8-13.3 | X | |
| A-XT-09W(8) | 12.4-16.8 | X | |
| A-XT-08W(9) | 15.8-21.3 | X | |
| A-XT-08W(10) | 20-27 | X | |
| A-XT-07W(11) | 25.3-34.3 | X | |
| A-XT-10W(12) | 32.1-43.4 | X | |
| A-XT-11W(13) | 44-66 | X |
II-2
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II-3
Additional Information I for K102825 Blood Pressure Cuff -Attachment II 510(k) Summary
The device was tested per ISO 10993 series standards to evaluate its Testing Summary biocompatibility and AAMI SP10:2002+A1:2003+A2:2006. The proposed devices, Blood Pressure Cuff, are claimed to be Substantially SE Conclusion Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff, K08085 and Tytan Blood Pressure Cuff, K062238.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APK Technology Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA
MAR - 2 2011
Re: K102825
Trade/Device Name: Disposable Blood Pressure Cuff Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: January 25, 2011 Received: January 28, 2011
Dear Ms. Hong:
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 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 - Ms. Diana Hong
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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Additional Information I for K102825 Blood Pressure Cuff -- Attachment I Indication for Use Statement
Attachment I Indication for Use Statement
510(k) Number: K102825 Device Name: Blood Pressure Cuff
Indications for Use:
Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Len for BZuckerman
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Bivision Sian-Off
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§ 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).