(38 days)
Not Found
No
The device description and intended use clearly describe a simple, disposable blood pressure cuff and tube set, with no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies refer to conformance to standards, not algorithmic performance.
No
The device is described as a blood pressure cuff for monitoring blood pressure, not for treating any medical condition.
Yes
The device is used for "determination of a persons blood pressure," which is a measurement taken to diagnose or monitor medical conditions related to blood pressure.
No
The device description clearly outlines physical components like a bladder, tube set, cuff, and connectors, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine a person's blood pressure. This is a physiological measurement taken directly from the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The device is a blood pressure cuff and tube set. It's a mechanical device used to apply pressure to an artery to measure blood pressure. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures for analyzing biological samples, which are hallmarks of IVD devices.
Therefore, based on the provided information, this device is a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
Product codes
DXO, DXQ
Device Description
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs consists of a cuff bladder manufactured from polyester reinforced vinyl. The cuff is closed with a hook and loop fastening system (Velcro Loop with vinyl backing and YKK PVC hook). The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are disposable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC or Nylon) for use with most monitoring systems.
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)
Not Found
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
Attachment III
510(k) Summary
January 15, 2004 Ethox Corporation 251 Seneca Street Buffalo, New York USA 14204-2088 Voice: 716-842-4000, Toll-Free: 1-800-521-1022, Fax: 716-842-4040 Regulatory Contact: Eon Verrall; VP of Quality and Regulatory Affairs E-mail: verrall(@ethoxcorp.com
-
- Identification of the Device:
Proprietary-Trade Name: Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs Classification Name: Blood Pressure Cuff, 21CFR870.1120 Product Code: DXO Common/Usual Name: Blood Pressure Cuff
- Identification of the Device:
-
Equivalent legally marketed device Blood-Pressure Cuff: Ethox Corp. SURGI-2. CUF® Adult Blood Pressure Cuffs, K883977
-
- Indications for use (Intended Use): This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
-
- Description of the Device: The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs consists of a cuff bladder manufactured from polyester reinforced vinyl. The cuff is closed with a hook and loop fastening system (Velcro Loop with vinyl backing and YKK PVC hook). The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are disposable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC or Nylon) for use with most monitoring systems. Refer to Attachment VII for product engineering drawings for each model family.
Product Family Description*
| Family | Number of Tubes | Connector Type |
|---|---|---|
| 510X | 1 | Female Luer Lock |
| 520X | 2 | Multipurpose Screw Connector |
| 540X | 1 | Quick-disconnect Connector |
- Each product family comes in 6 sizes: 15-22 cm, 17-25 cm, 24-32 cm, 28-32 cm, and 42-50 cm
-
- Safety and Effectiveness, comparison to predicate device:
See Table on Next Page
- Safety and Effectiveness, comparison to predicate device:
Image /page/0/Picture/15 description: The image shows the logo for Ethox Corp. The logo consists of a stylized letter "E" made up of triangles on the left, followed by the word "ethox" in a bold, sans-serif font. The letters are connected to each other. Below the word "ethox" is the word "CORP." in a smaller font size.
251 Seneca Str Buffato, New York 14204-2088 716-842-4000 FAX 716-842-4040
E-Mail: info@ethoxcorp.com Web Site: www.ethoxcorp.com
1
| 0
| CORP. |
|---|
| ------------ |
251 Seneca Street
- Buffalo, New York
14204-2088
14204-2088
716-842-4000 FAX 716-842-4040 E-Mail:
info@ethoxcorp.com Web Site:
www.ethoxcorp.com
| Element of
comparison | Originally cleared device
(K883977) | Current Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For Monitoring Blood pressure.
Single patient use only. Sterile &
non-sterile. | For Monitoring Blood pressure. Disposable.
Non-sterile versions only. |
| Materials | | |
| Cuff material | PVC | Vinyl with polyester reinforcement |
| Connectors | Cycolac (ABS) | Nylon or PVC (See Summary under
biocompatibility) |
| Tube | PVC | Maclin PVC VE-2855 |
| Fastener | Velcro hook & loop | Velcro Loop with vinyl backing, YKK PVC hook |
| Stub | PVC | PVC |
| Marking | Not specified in original 510(k). | Green hot-stamp (Currently in the process of
switching) |
| Bonding agent | Cylcohexanone | Cylcohexanone |
| Biocompatability | (Refer to Attachment VIII For Supporting Data) | |
| Primary Cuff Material | (PVC) USP Class III.
Printing on Cuff not specified | (Vinyl with polyester reinforcement) with
printing currently being tested to FDA blue book
memorandum #G95-1 requirements for prolonged
skin contact. Refer to Attachment VIII Item 1.
Product will only be released upon completion of
this testing with acceptable results. |
| Stub | PVC USP Class III | PVC Non-patient contact item (Performed MEM
Elution Cytotoxicity testing found to be non-
toxic. Performed Physico-Chemical Tests - C19
Found to meet USP Limits). Refer to Attachment
VIII Item 2. |
| Connectors | Cycolac (ABS) USP Class III | Various -- See below (All non-patient contact
items. |
| Female Luer | NA | Nylon: USP Class II and Cytotoxicity MEM
Elution. Refer to Attachment VIII Item 3. |
| Quick Disconnect
Connector | NA | Nylon: USP Class II and Cytotoxicity MEM
Elution. Refer to Attachment VIII Item 3. |
| Multi-purpose screw
connector | NA | PVC USP Class VI. Refer to Attachment VIII
Item 4. |
| Tube | PVC USP Class III | Virgin PVC (Constituent materials USP Class VI
) Refer to Attachment VIII Item 5. |
| General Cuff Design | Refer to Attachment 9 for product
drawings of predicate device. | Refer to Attachment VI for product photographs
and Attachment VI for product drawings |
| Connectors | 1 option:
Tapered connector to fit with
most standard luer connectors. | 3 Options:
- Female Luer Connector: 510X Series
- Quick Disconnect Connector: 540X Series
- Multi-purpose Screw Connector (2 Tubes /
2 connectors): 520X Series |
| Cuff | No changes to general cuff design aside from material changes referenced above. | |
| Sizes | 7
Min. 17.0 cm Max. 25.0 cm
8
Min. 25.0 cm Max. 35.0 cm
9
Min. 32.0 cm Max. 42.0 cm
10
Min. 42.0 cm Max. 50.0 cm | 6 Min. 15.0 cm Max. 22.0 com
7 Min. 17.0 cm Max. 25.0 cm
8 Min. 25.0 cm Max. 35.0 cm
8P Min. 28.0 cm Max. 37.0 cm
9 Min. 32.0 cm Max. 42.0 cm
10 Min. 42.0 cm Max. 50.0 cm |
| Performance | Conforms to American Heart
Association recommendations | Conforms to American Heart Association
recommendations. The 540X and 520X series
conform to EN1060-1,2, & 3 |
| Target Population | Sizes from 17.0 cm to 50.0 cm | Sizes from 15.0 cm to 50.0 cm |
| Features | Compatible with most monitors | Compatible with most monitors. Latex Free. |
| Labeling | Predicate Device labeling provided in
Attachment IX | Current labeling provided in Attachment IV |
2
In all respects, the Ethox "SURGI-CUF Adult Disposable Blood Pressure Cuffs are substantially equivalent to the originally cleared devices (Ethox Corp. SURGI-CUFF The intended use, product function and design are substantially K883977). equivalent to the predicate device. All material changes to patient contact components are with materials that have been tested to equivalent, or more stringent, biocompatibility standards than the predicate device. In addition, changes in features/general design relate to size and adapter types which are improvements over the predicate device, allowing the product line to service a larger patient population and work with a wider range of ancillary monitoring equipment.
Image /page/2/Picture/1 description: The image shows the logo for Ethox Corp. The logo is black and white and features a stylized letter "E" followed by the word "thox" in a bold, sans-serif font. Below the word "thox" is the word "CORP." in a smaller font size. The logo also includes a registered trademark symbol.
251 Seneca Street Buffalo, New York 14204-2088 716-842-4000
FAX 716-842-4040
E-Mail: info@ethoxcorp.com Web Site: www.ethoxcorp.com
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR | 5 2004
Ethox Corporation c/o Mr. Ned Devine Responsible Official Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K040286
Trade Name: Ethox SURGI-CUF Adult Disposable Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: March 4, 2004 Received: March 5, 2004
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.
4
Page 2 - Mr. Ned Devine
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Lachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment II
Statement of Indications for Use
510(k) Number: K640286
Device Name: Ethox SURGI-CUF Adult Disposable Blood Pressure Cuffs
Indications for Use: A non-sterile disposable inflatable bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
V Prescription Use (Part 21 CFR 801 Subpart D)
_______ ... ... ...
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dorna R. Lochner
(Division Sir -Off) Division of Catalovascular Devices
510(k) Number_k 040286