(38 days)
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.
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.
This document describes an FDA 510(k) premarket notification for a traditional medical device (blood pressure cuffs), not an Artificial Intelligence (AI)/Machine Learning (ML) device. As such, most of the requested information regarding AI/ML device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and standalone performance) is not applicable.
However, I can provide information about the acceptance criteria and the methods used to demonstrate substantial equivalence for this device.
Acceptance Criteria and Device Performance
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are a conventional medical device. The acceptance criteria primarily revolve around demonstrating substantial equivalence to a predicate device (Ethox Corp. SURGI-2. CUF® Adult Blood Pressure Cuffs, K883977) in terms of intended use, safety, and effectiveness. Key performance criteria are related to biocompatibility and compliance with recognized standards.
Here's a table summarizing the acceptance criteria and reported device performance based on the provided document:
| Acceptance Criteria Category | Specific Criteria/Performance Goal | Reported Device Performance/Evidence |
|---|---|---|
| Intended Use | For monitoring blood pressure. | Met: "This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure." (Same as predicate device). "Disposable. Non-sterile versions only." (Predicate was single patient use, sterile & non-sterile). |
| Biocompatibility | All patient contact components meet equivalent or more stringent biocompatibility standards than the predicate device. | Met: - Primary Cuff Material (Vinyl with polyester reinforcement): "printing currently being tested to FDA blue book memorandum #G95-1 requirements for prolonged skin contact. Product will only be released upon completion of this testing with acceptable results."- Stub (PVC): "Performed MEM Elution Cytotoxicity testing found to be non-toxic. Performed Physico-Chemical Tests - C19 Found to meet USP Limits."- Female Luer (Nylon): "USP Class II and Cytotoxicity MEM Elution."- Quick Disconnect Connector (Nylon): "USP Class II and Cytotoxicity MEM Elution."- Multi-purpose screw connector (PVC): "USP Class VI."- Tube (Virgin PVC): "Constituent materials USP Class VI." |
| Performance Standards | Conforms to American Heart Association (AHA) recommendations. | Met: "Conforms to American Heart Association recommendations." |
| Additional Standards | (For 540X and 520X series) Conforms to EN1060-1,2, & 3. | Met: "The 540X and 520X series conform to EN1060-1,2, & 3." |
| Materials | Materials are suitable for the intended use and demonstrate equivalency/improvement over predicate. | Met: Detailed comparison of materials provided (e.g., cuff material changed from PVC to Vinyl with polyester reinforcement; connectors changed from Cycolac (ABS) to Nylon or PVC). All changes supported by biocompatibility testing. |
| General Design | Maintain core function while allowing for improvements in size range and connector options. | Met: "No changes to general cuff design aside from material changes referenced above." "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." |
| Sizes | Offer a range of sizes appropriate for the target population. | Met: Expanded size range from 15.0 cm to 50.0 cm (predicate was 17.0 cm to 50.0 cm), including a new 8P size. |
| Features | Compatible with most monitors. | Met: ("Compatible with most monitors. Latex Free."). The predicate device was also compatible with most monitors. |
| Labeling | Labeling clearly defines the device's characteristics and use. | Met: Current labeling provided in Attachment IV. |
Non-Applicable AI/ML Device Study Information:
Given that the device in question is a conventional disposable blood pressure cuff and not an AI/ML device, the following points are not applicable to the provided documentation:
- Sample size used for the test set and the data provenance: Not applicable for a non-AI/ML device. Testing focuses on material properties, biocompatibility, and compliance with performance standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for blood pressure cuffs refers to their physical properties and performance against established standards, not expert consensus on interpretations.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" would be objective measurements of material properties (e.g., tensile strength, cytotoxity assay results), compliance with dimensional specifications, and adherence to established performance standards (like AHA recommendations or EN1060).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Substantiation:
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs demonstrate substantial equivalence through:
- Comparison to a Predicate Device: Detailed comparison table outlining similarities and differences in intended use, materials, design, sizes, and performance.
- Biocompatibility Testing: Extensive testing (e.g., USP Class III, USP Class II, USP Class VI, MEM Elution Cytotoxicity testing, Physico-Chemical Tests - C19, FDA blue book memorandum #G95-1 requirements) for all patient contact components to ensure safety and compliance.
- Compliance with Recognized Standards: Conformance to American Heart Association recommendations and EN1060-1,2, & 3 for specific series, indicating reliable performance.
- Design and Feature Improvements: Changes such as an expanded size range and diverse connector options are presented as improvements that broaden product utility while maintaining the core function.
The overall conclusion is that the device's intended use, product function, and design are substantially equivalent to the predicate device, and any material changes meet equivalent or more stringent biocompatibility standards.
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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
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| 0CORP. |
|---|
| ------------ |
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 ofcomparison | 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 underbiocompatibility) |
| 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 ofswitching) |
| 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) withprinting currently being tested to FDA blue bookmemorandum #G95-1 requirements for prolongedskin contact. Refer to Attachment VIII Item 1.Product will only be released upon completion ofthis testing with acceptable results. |
| Stub | PVC USP Class III | PVC Non-patient contact item (Performed MEMElution Cytotoxicity testing found to be non-toxic. Performed Physico-Chemical Tests - C19Found to meet USP Limits). Refer to AttachmentVIII Item 2. |
| Connectors | Cycolac (ABS) USP Class III | Various -- See below (All non-patient contactitems. |
| Female Luer | NA | Nylon: USP Class II and Cytotoxicity MEMElution. Refer to Attachment VIII Item 3. |
| Quick DisconnectConnector | NA | Nylon: USP Class II and Cytotoxicity MEMElution. Refer to Attachment VIII Item 3. |
| Multi-purpose screwconnector | NA | PVC USP Class VI. Refer to Attachment VIIIItem 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 productdrawings of predicate device. | Refer to Attachment VI for product photographsand Attachment VI for product drawings |
| Connectors | 1 option:Tapered connector to fit withmost standard luer connectors. | 3 Options:1. Female Luer Connector: 510X Series2. Quick Disconnect Connector: 540X Series3. Multi-purpose Screw Connector (2 Tubes /2 connectors): 520X Series |
| Cuff | No changes to general cuff design aside from material changes referenced above. | |
| Sizes | 7Min. 17.0 cm Max. 25.0 cm8Min. 25.0 cm Max. 35.0 cm9Min. 32.0 cm Max. 42.0 cm10Min. 42.0 cm Max. 50.0 cm | 6 Min. 15.0 cm Max. 22.0 com7 Min. 17.0 cm Max. 25.0 cm8 Min. 25.0 cm Max. 35.0 cm8P Min. 28.0 cm Max. 37.0 cm9 Min. 32.0 cm Max. 42.0 cm10 Min. 42.0 cm Max. 50.0 cm |
| Performance | Conforms to American HeartAssociation recommendations | Conforms to American Heart Associationrecommendations. The 540X and 520X seriesconform 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 inAttachment IX | Current labeling provided in Attachment IV |
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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
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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.
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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
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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
§ 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).