(13 days)
Not Found
No
The device description and intended use are for a standard, reusable blood pressure cuff. There is no mention of AI or ML in the provided text, and the performance studies are based on standard medical device testing protocols.
No.
The device is a blood pressure cuff used for diagnostic purposes (determination of blood pressure) and not for treating a disease or condition.
No
Explanation: The device is a blood pressure cuff, which is an accessory used with blood pressure monitoring systems. It facilitates the measurement of blood pressure, but it does not perform the diagnosis itself. The "determination of a person's blood pressure" is a measurement, not a diagnosis.
No
The device description clearly outlines a physical blood pressure cuff with a bladder, tubes, connectors, and fastening system, indicating it is a hardware device.
Based on the provided information, the SURGI-CUF® REUSABLE Blood Pressure Cuff is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "determination of a persons blood pressure" by being used in conjunction with blood pressure monitoring systems. This is a direct measurement of a physiological parameter in a living person.
- Device Description: The device is a physical cuff and tube set designed to be applied externally to the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis on biological specimens.
The device is clearly an in vivo medical device used for measuring a physiological parameter directly on a patient.
N/A
Intended Use / Indications for Use
Indirect measurement of blood pressure
The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
Product codes
DXQ
Device Description
The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems.
Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:
- Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)
- Single Tube configuration with 6 types of connectors
- Double Tube configuration with 2 types of connectors
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and laboratory testing to demonstrate safety and effectiveness per:
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers
- AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing User Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K061962
p 1/2
Attachment 3
510(k) Summary
| Date: | April 19, 2006 |
|---|---|
| Submitter: | Ethox International, Inc. |
| 251 Seneca Street | |
| Buffalo, New York USA 14204-2088 | |
| Tel: 716-842-4000 | |
| Fax: 716-842-4040 | |
| JUL 25 2006 | |
| John Riggi, VP of Quality Assurance & Regulatory Affairs | |
| riggi@ethoxint.com | |
| Device Name: | SURGI-CUF® REUSABLE Blood Pressure Cuffs |
| Common/ Usual Name: | Blood Pressure Cuff |
| Product Code/ Classification: | DXQ / 21CFR870.1120 |
| Intended Use: | Indirect measurement of blood pressure |
| Indications for Use: | The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable. |
| Device Description: | The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems. |
| Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations: | |
| Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)Single Tube configuration with 6 types of connectorsDouble Tube configuration with 2 types of connectors |
"
:
1
Predicate
Devices:
The SURGI-CUF® REUSABLE Blood Pressure Cuff is substantially equivalent to the following predicate devices:
K022482; Sensa-Cuff; GE Medical Systems Information Technologies
Preamendent; CRITIKON DURA-CUF®; Critikon Company, LLC.
K040286, SURGI-CUF®; Ethox Corporation
The SURGI-CUR® REUSABLE Blood Pressure Cuff has the same intended use and general construction as the predicate devices. All four devices contain a bladder and hook & look fastening system. The SURGI-CUF® REUSABLE and DURA-CUF® arc made of the same material. The SURGI-CUF® REUSABLE and SURGI-CUF® are available in the same sizes.
Performance:
Bench and laboratory testing to demonstrate safety and effectiveness per:
б
- AAMI SP10:2002, Manual, electronic or automated sphygmomanometers
- AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing User Validation
2
Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JUL 25 2006
Ethox International, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Service NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087
Re: K061962
Trade Name: SURGI-CUF® REUSABLE Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 11, 2006 Received: July 12, 2006
Dear Mr. Devine:
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.
3
Page 2 - Mr. Neil E. Devine, Jr.
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 (OS) 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. Zukerman, MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
Statement of Indications for Use
Device Name: SURGI-CUF® REUSABLE Blood Pressure Cuffs
Indications for Use: The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is nonsterile and reusable.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IIi NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brimmin
(Division Sign-Off) Division of Cardlovascular Dovices 510(k) Number K/ v/962