(57 days)
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Not Found
No
The device is explicitly described as "non-automated, mechanical" and there are no mentions of AI, ML, or related concepts.
No
The device is used for the "non-invasive indication of blood pressure," which is a diagnostic purpose, not a therapeutic one. It measures blood pressure rather than treating a condition.
Yes
The device is a blood pressure sphygmomanometer, which non-invasively indicates blood pressure. Measuring blood pressure provides information that can be used to diagnose various medical conditions.
No
The device is described as a "non-automated, mechanical blood pressure sphygmomanometer," which is a hardware device.
No, this device 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 TRIMLINE Large Face Aneroid Sphygmomanometer is a mechanical device that measures blood pressure directly on the patient's body (non-invasively). It does not analyze samples taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRIMLINE Large Face Aneroid Sphygmomanometer: is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure. may be used with neonatal, pediatric and adult patients
Product codes
74 DXQ
Device Description
The TRIMLINE Large Face Aneroid Sphygmomanometer: is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure.
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
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The eagle is depicted with its wings spread, symbolizing strength and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
TRIMELINE Medical Products Corporation c/o Ms. Nancy Skopec Regulatory Affairs Specialist 34 Columbia Road Branchburg, NJ 08876
OCT 2 1 2009
Re: K092604
Trade/Device Name: TRIMELINE Large Face Aneroid Sphygmomanometer Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ Dated: August 6, 2009 Received: August 25, 2009
Dear Ms. Skopec
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.
1
Page 2 - Ms. Nancy Skopec
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
STATE SERVER BER SERVER PLAND SERVER SELLERS SELLER SELLE
bunu R. lahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
TRIMLINE Medical Products Corporation
510(k) Premarket Notification
092604
INDICATIONS FOR USE 4
K092604 510(K) Number:
Device Name: TRIMLINE™ Large Face Aneroid Sphygmomanometer
Indications for Use:
The TRIMLINE Large Face Aneroid Sphygmomanometer:
is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure.
may be used with neonatal, pediatric and adult patients
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (Part 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2.1 DU MANS
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K097604