(203 days)
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No
The summary describes a blood pressure cuff, a purely mechanical accessory, and contains no mention of AI, ML, or any related computational processing.
No
The device is a blood pressure cuff, which is an accessory used for measurement, not for therapy or treatment.
No
Explanation: The device is an accessory (blood pressure cuff) used with blood pressure measuring systems. It does not perform a diagnostic function itself but rather facilitates the measurement.
No
The device is described as a "Blood Pressure Cuff," which is a physical hardware component used in conjunction with blood pressure measuring systems. The summary does not mention any software-only functionality.
Based on the provided information, the TRIMLINE Tempa-Kuff Blood Pressure Cuff is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory used with non-invasive blood pressure measuring systems. This involves measuring a physiological parameter (blood pressure) directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The blood pressure cuff does not perform such tests.
Therefore, the TRIMLINE Tempa-Kuff Blood Pressure Cuff falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRIMLINE Tempa-Kuff Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring systems. It is non-sterile and may be used on a limited basis with neonatal, pediatric and adult patients.
Product codes
DXQ
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, pediatric and adult patients
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2008
TRIMLINE Medical Products Corporation c/o Ms. Nancy Skocypec Regulatory Affairs Manager 34 Columbia Road Branchburg, NJ 08876
Re: K080189
TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood pressure cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: August 7, 2008 Received: August 11, 2008
Dear Ms. Skocypec:
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 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.
1
Page 2 - Ms. Nancy Skocypec
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,
Qmpl
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 4
510(K) Number: K080189
Device Name: TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff
Indications for Use:
"
The TRIMLINE Tempa-Kuff Blood Pressure Cuff:
- is an accessory used in conjunction with non-invasive blood pressure measuring systems
- is non-sterile and may be used on a limited basis :
- . may be used with neonatal, pediatric and adult patients
| Prescription Use | AND/OR | Over-The Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | X (Part 21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K080189 |