(307 days)
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No
The summary describes a standard blood pressure cuff and does not mention any AI or ML components or functionalities.
No
The device is solely for determining blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is used to determine a person's blood pressure, which is a physiological measurement used in diagnosis.
No
The device description clearly states it is a "Blood Pressure Cuff," which is a physical hardware component used for measuring blood pressure. The summary does not mention any software component as the primary or sole function of the device.
Based on the provided information, the Medline Single Patient Use Blood Pressure Cuff is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The blood pressure cuff is a device used externally on the body to measure blood pressure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "determination of a person's blood pressure" in conjunction with a monitoring system. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Medline Single Patient Use Blood Pressure Cuff falls under the category of a non-invasive medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.
Product codes
DXO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatal, infant, and adult sizes
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 2008
Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Specialist One Medline Place Mundelein, IL 60060
Re: K071244
Trade/Device Name: Medline Single Patient Use Blood Pressure Cuffs:
| Description | Part Numbers |
|---|---|
| Neonatal, single tube | MDS9741/9742/9743/9744/9745 |
| Neonatal, double tube | MDS9751/9752/9753/9754/9755 |
| Infant - Adult, Disposable double tube | MDS9710/9711/9712/9713/9714/9715 |
| Infant - Adult, Disposable single tube | MDS9720/9721/9722/9723/9724/9725 |
Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuffs Regulatory Class: Class II (Two) Product Code: DXO Dated: February 1, 2008 Received: February 4, 2008
Dear Mr. Clausen:
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. Matt Clausen
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.Bermmurafe
Bram B. 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): ____________________________________________________________________________________________________________________________________________________
Device Name:__Medline Single Patient Use Blood Pressure Cuff
Indications For Use:
The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhummer
Diction of Cardiovascular Deviçes 516.kg Number
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