(177 days)
This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
This device is a cover for blood pressure cuffs. It is made non-woven polypropylene with a polyethylene coating. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
The provided text describes a 510(k) premarket notification for the Ethox CUF-COVERTM, a blood pressure cuff cover. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the BOWEN MEDICAL SERVICES, INC. CUFF GUARD (K952825).
Based on the provided information, I can answer some of your questions, but many of the specific details you've asked for, particularly regarding new device acceptance criteria and study particulars for a modern AI/ML device, are not present in this document, as this is a traditional medical device submission from 2003.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is primarily done by showing similar intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Ethox CUF-COVER™) |
|---|---|
| Intended Use: Reduce/prevent patient-to-patient cross-contamination during BP measurement, provide barrier between patient and cuff. | SAME as predicate, "except for single patient use only." (This is a slight difference but considered acceptable for equivalence, potentially improving safety). |
| Materials: Appropriate for the intended use and provide barrier function. | Thin non-woven polypropylene with a polyethylene coated inner layer. (Compared to "White spun plastic" of the predicate). Laboratory testing shows material is an effective microbial and air barrier. |
| Safety: Does not significantly affect diagnostic measurements (e.g., blood pressure). | Clinical testing shows the cover does not significantly affect blood pressure readings. |
| Effectiveness: Provides a barrier function against contamination. | Laboratory testing shows the material is an effective microbial and air barrier. Potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. |
| Technological Characteristics: Similar design and function. | Made non-woven polypropylene with a polyethylene coating, single-patient use, clean, ready-to-use sleeve, Zip-Lock closure (vs. adhesive tape for predicate), translucent (vs. opaque for predicate). Sizes: Small, Medium, Large (vs. 6 sizes for predicate). Differences are judged not to raise new questions of safety or effectiveness. |
Study Information (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Clinical Testing: The document mentions "Clinical testing shows the cover does not significantly affect blood pressure readings." However, the sample size and data provenance (e.g., country of origin, retrospective/prospective) for this clinical testing are NOT provided.
- Laboratory Testing: "Laboratory testing shows the material is an effective microbial and air barrier." Details on the sample size or methods for this lab testing are NOT provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. This is a traditional device; the "ground truth" here is the physical performance and safety characteristics, not interpretations by experts of diagnostic images or data. The "ground truth" for the material barrier claims would be established by standard microbiological and material integrity tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to expert consensus in diagnostic studies (e.g., radiology). For this device, standard laboratory and clinical methods are used, not expert adjudication in that sense.
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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:
- No, an MRMC study was NOT done. This is a physical medical device (blood pressure cuff cover), not an AI/ML diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is irrelevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone study was NOT done. Again, this is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the barrier function: Laboratory test results demonstrating effectiveness as a microbial and air barrier would serve as the "ground truth."
- For the impact on blood pressure readings: Clinical measurements demonstrating that the cover does not significantly alter BP readings would be the "ground truth."
- For cross-contamination reduction: This is inferred from the barrier function and the single-patient use design, aligning with the intended use.
- Essentially, the ground truth is based on objective physical and physiological measurements from laboratory and clinical tests, not expert consensus on diagnostic interpretations.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML product, so there is no concept of a "training set" in the context of machine learning. The device design and materials are based on standard engineering and medical principles.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
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OCT 1 0 2003
EXHIBIT 2
Image /page/0/Picture/3 description: The image shows a logo with the word "Ethox" in bold, stylized letters. Below "Ethox" is the word "CORP." The logo has a geometric design to the left of the word "Ethox", which appears to be a stylized letter E.
251 Seneca Street Buffalo, New York USA 14204-2088 Voice: 716-842-4000 Toll-Free: 1-800-521-1022 Fax: 716-842-4040 E-mail: info@ethoxcorp.com Contact: Dodi Kingsfield Quality Systems and Regulatory Affairs Manager 510(k) Summary
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- Identification of the Device: Proprietary-Trade Name: Ethox CUF-COVERTM Classification Name: Blood pressure cuff, Product Code: DXQ Common/Usual Name: Blood pressure cuff cover.
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- Equivalent legally marketed device: CUFF GUARD, BOWEN MEDICAL SERVICES, INC. K952825
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- Indications for Use (intended use). This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff..
- Description of the Device: This device is a cover for blood pressure cuffs. It is made non-4. woven polypropylene with a polyethylene coating. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination. When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff cover can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff cover has been designed. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
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| Element of Comparison | Bowen MedicalCuff-Guard K952825 | Ethox CUF-COVER™ |
|---|---|---|
| Intended Use | This device is has thepotential to reduce orprevent patient to patientcross contaminationwhich can occur duringblood pressuremeasurement procedures.Covers a blood pressurecuff to provide a barrierbetween patient and cuff.(reusable (cleanable). | SAME except for singlepatient use only |
| Materials | White spun plastic andVelcro closure | Thin non-wovenpolypropylene with apolyethylene coated innerlayer. The sheet is foldedover and the inner polylayer welded togetheralong each end. Velcroclosure. |
| Sizes | Six sizes: Newborn,Infant, Child, Adult,Large Adult, Thigh | Small, Medium, Large |
| Closure | Two sided adhesive tapewith removable liner | Zip-Lock |
| Cover material | Opaque | Translucent |
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- Safety and Effectiveness, comparison to predicate device:
- Conclusion: In all respects, the Ethox CUF-COVERs™ are substantially equivalent to 6. Bowen Medical Cuff-Guard. The covers are made of similar materials. Laboratory testing shows the material is an effective microbial and air barrier. Clinical testing shows the cover does not significantly affect blood pressure readings.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Ethox Corp. c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K031195
Trade Name: Cuf-Cover™ Regulation Number: 21 CFR §870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: September 2, 2003 Received: September 5, 2003
Dear Mr. Kamm:
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. Daniel Kamm
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 vours.
Afelaimap
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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j) Indications for Use
510(k) Number
Device Name: CUF-COVER™
This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X O OR Over the Counter Use (Per 21 CFR 801.109)
lmesl Maya for BDZ
(Division Sign Off)
510:KI Num
§ 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).