(100 days)
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
The proposed devices, Disposable blood Pressure Cuff, are claimed to be Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.
The provided text describes the acceptance criteria and the study for a Disposable Blood Pressure Cuff.
Here's the information extracted and organized:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested per ISO 10993 series standards. |
| Performance | Tested per AAMI SP10:2002+A1:2003+A2:2006. |
| Substantial Equivalence | Found to be substantially equivalent (SE) to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of an algorithm or AI. Instead, it refers to standards for evaluating biocompatibility and performance of a physical device.
- Test Set Sample Size: Not explicitly stated for specific human subjects or data points, but implies adherence to the sample size requirements of ISO 10993 and AAMI SP10 for device testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The manufacturer is Wuxi Medical Instruments Factory in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is not an AI or algorithm-based device that would require expert-established ground truth for a test set. The "ground truth" for this device relates to its physical performance and biocompatibility according to established medical device standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI or algorithm-based device that would require an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a physical medical device (blood pressure cuff), not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device (blood pressure cuff). The concept of "standalone performance" for an algorithm is not applicable. The device's performance is tested according to AAMI SP10, which evaluates the physical function of the cuff.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by adherence to recognized international standards:
- Biocompatibility: ISO 10993 series standards.
- Performance: AAMI SP10:2002+A1:2003+A2:2006.
- Substantial Equivalence: Comparison to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.
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Premarket Notification Traditional Section 510(k) Submission . The device was tested per ISO 10993 series standards to evaluate its biocompatibility Testing Summary and AAMI SP10:2002+A1:2003+A2:2006 to evaluate its perfromance The proposed devices, Disposable blood Pressure Cuff, are claimed to be SE Conclusion Substantially Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wuxi Medical Instruments Factory c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 CHINA
JAN - 7 2011
Re: K102823
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: September 28, 2010 Received: September 29, 2010
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/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 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,
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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Premarket Notification Traditional Section 510(k) Submission
Attachment I Indication for Use Statement
510(k) Number: K102823 Device Name: Disposable blood Pressure Cuff
- 7 2011 JAN
Indications for Use:
Disposable blood Pressure Cuff is intended to be wrapped on the upper arm and used with a non-invasive blood pressure device to determine blood parameters on neonate, pediatric and adult patients.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __x (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)
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W.A. West.
in-Off) ardiovascular Devices
510(k) Number K102823
§ 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).