(292 days)
Not Found
No
The device description and performance studies focus on a physical barrier (non-woven paper drape) for blood pressure cuffs and do not mention any computational or algorithmic functions, let alone AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is intended to cover blood pressure cuffs to protect patients and healthcare workers from contamination, not to provide therapy or directly treat a disease or condition.
No
Explanation: The device is designed to cover blood pressure cuffs for hygiene and protection, not to diagnose medical conditions or provide diagnostic information. Its function is protective and acts as a barrier, with no mention of measuring, analyzing, or interpreting physiological signals for diagnostic purposes.
No
The device description clearly states it is a physical product made of non woven paper drape with adhesive tape, designed to cover blood pressure cuffs. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover blood pressure cuffs to protect against contamination during application to a patient. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a non-woven paper drape with adhesive. This is a physical covering, not a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions.
- Lack of Diagnostic Function: The device does not analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. It is a protective barrier.
- Performance Studies: The performance studies focus on the impact of the device on blood pressure measurement accuracy, not on its ability to detect or measure substances in a biological sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Cuff Saver does not fit this description.
N/A
Intended Use / Indications for Use
The intended use of the Cuff Saver will be to cover all types of blood pressure cuffs and/or cuff bladders prior to the cuff or cuff bladder being applied to the patient. This will protect the patient and the care worker from overt and covert exposure to contaminated blood pressure cuffs.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The Camouflage Cuff Saver is essentially a non woven paper drape that can cover/contain a reusable blood pressure cuff, a disposable cuff, or a cuff bladder. It is fluid repellent and acts to ensure a clean cuff for each patient as it is discarded after single patient use. It is manufactured of medical grade Sontara non woven fiber with 3M brand double sided adhesive tape as a fastening along one vertical edge of the unit and an adhesive patch located on the printed side of the unit. This patch is used to secure the device to its own surface after the device and the cuff it covers are applied to the patients arm. As stated, the device is printed with a design and typical marking for a blood pressure cuff (Artery placement, Range line, etc.). It is available on a perforated roll so that the user can tear off one unit at a time just as one removes a paper towel from its roll.
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
Health care workers / hospital
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)
Clinical tests performed by N. A. Bragge Medical, Inc. on seventeen human volunteers of various sizes and upper arm circumference provide credible proof. Tests were performed with standard sizes of commercially available blood pressure cuffs of both the reusable and disposable varieties. Cuffs of the bladder type and the bladderless type were tested with and without the application of the Camouflage Cuff Saver device. The Cuff Saver was also tested with the standard commercially available inflation bladder with the Cuff Saver covering the bladder and the Cuff Saver acting as the Cuff itself. Each subjects pressure was taken in the order listed with a three minute waiting period between each measurement. The pressures were taken using a Dinamap Brand noninvasive blood pressure machine. Measurement accuracy was confirmed by checking the Dinamap machine against pressure taken with a calibrated mercury sphygmomanometer. For accuracy, cuffs used on each volunteer were at least 40% as wide as the circumference of the subjects upper arm. All subjects were awake and in an unaltered state of awareness during the testing.
The finding of the testing process showed no discernible or appreciable difference between the blood pressures taken with the conventional blood pressure cuffs and those fitted with the Camouflage Cuff Saver device. There was also no appreciable or discernible difference between the blood pressures taken with the conventional cuff and those taken with the Camouflage Cuff Saver fitted with the standard inflation bladder. All of the measurements obtained to the data acceptance limits set forth in the testing protocol and all results conformed to the pass fail criteria of a 95% Confidence interval of 4.3 or less derived from data collected from measurement of blood pressure taken with the calibrated Dinamap brand blood pressure machine and the two industry standard cuffs used in the study. Minor fluctuations in the results obtained are attributed to the dynamic state of blood flow within the cardiovascular system and are physiologic in nature. In conclusion, Camouflage Cuff Savers offer the public a functional, inexpensive alternative to the current disposables on the market today and provide a public health benefit to the general population by reducing the incidence of cross-contamination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
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510K Summary
JUL 2 3 1997
Submitter N.A. Braggs Medical, Inc. Jacqueline Brackett, C.E.O. 8255 Brackctt Lanc Semmes, Al. 36575 Phone: (334) 649-4414 Fax: (334) 660-6288
Contact Person- Jacqueline Brackett 8255 Brackett Lane Semmes, Al. 36575
Date of Preparation- September 25, 1996 Date of Revision #1- January 8, 1997 Date of Revision #2- April 12, 1997
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1
Device Name- Camouflage Cuff Saver
Common Name- Cuff Protector/Bladder Cover
Rogistration Number- 1060936
Classification- Cardiovascular. No classification listed. Device not listed in 21 CFR Parts 862-892.
10-3
Legally Marketed Device to Which Equivalence is Claimed:
We claim equivalence to 21 CFR section 870.1120- Blood Pressure Cuff. Predicate devices to which equivalence is claimed listed below.
- Vital Signs Clean Cull- K912638
-
- Criticall Disposables ( no number on recording to the Southeast Region Small Business Office of the FDA ).
- Bowen Medical Services Cuff Guard- K952825
10-4
Identification of the Equivalent Device:
We compare the Cull Saver, which is essentially a paper drape, to two (2) known disposable blood pressure cuffs ( Vital Signs Clean Cuff K912638 and Criticon Disposables [no K number] Hoth of these are viny//latex composition and are lubeled in print by the manufacturer for single patient use. We also compare our device to Bowen Medical Cuff Guard K952825. Our device is less costly than our competitors (~ $1.00 vs. > $5.00 ). As we understand the classification system, these vinyl/latex culls and covers considered Class 2. We also have identified Patcht Number 5,228,448 for u protective cover for blood pressure cuffs. The ubove identified cover is designed to be placed about the patient's arm and the blood pressure cuff is then placed atop the cover. The cover is folded over the cuff at that time. It is constructed of a two-ply labric with one layer being absorbent and the other fluid repellent. The construction and application of this device make it complicated to manufacturer and time consuming to use. At this time, we do not know of
2
10-4 (continued)
anyone offering this device for sale in the medical industry. Our product is manufactured of fluid repellent medical grade Sontara non woven fabric. Cannouflage Cuff Savers may also be used as the cuff itself when paired with the commercially available ouff inflation bag/oladder and, as such, serves to function as the disposable member of the blood pressure cuff in addition to it's role as a protective cover for reusable cuffs. The non woven fabric is a strong, fluid repellent substrate and the double sided adhesive tape used forms a strong secure hond when applied to the material. This allows the CulT Saver to cover a cuff Bladder and thus become a reliable blood pressure cuff for single patient use.
110-5
Description of the Device:
The Camouflage Cuff Saver is essentially a non woven paper drape that can cover/contain a usemal blood pressure cuff, a disposable cuff, or a cull bladder. It is fluid repellent and acts to ensure a clean cuff for each patient as it is discarded after single patient use. It is manufactured of medical grade Sontara non woven liber with 3M brand double sided adhesive tape as a fastening along onc vertical cdgc of the unit and an adhesive patch looated on the printed side of the unit. This patch is used to secure the device to its own surface after the device and the cuff it covers are upplied to the patients arm. As stated, the device is printed with a design and typical marking for a blood pressure cuff ( Artery placement, Range line, etc.). It is available on a perforated roll so that the user can tear off one unit at a time just as one removes a paper towel from its roll
It has been the concern of many health care workers that the blood pressure cutf is a potential source of contamination in the hospital cutts are difficult, it not impossible to clean and, more often than not, are never cleaned "Single use Unly" cuffs are used until they deteriorate and are also poorly cleaned. Hinod pressure cuffs used in the surgical suite remain on the patient when the patient is transported to the ICU or recovery room. This represents o poor understanding of infection control standards. The Cuff Saver attempts to address these problems by providing a clean, cost effective alternative to the current market.
Cuff Savers do not interfere with the performance of the functional coff that it serves to cover and may also be used as the cuff itself when used to cover a cull bladder. The Cuff Saver is soft, clean, covers the blood pressure cull, and after use, is discarded. This prevents contaminated wiffs from heing transmitted with their contaminates to the recovery or critical care areas of the hospital.
3
Intended Use of the Device;
The general intended use of the Cuff Saver will be to cover all blood pressure cuffs prior to being applied to the patient. As stated carlier, it can also cover a cuff bladder and be used as the cuff itself. When used as a cover or disposable blood pressure cuff, this will keep the patient from being oxposed to a dirty cuff and will also protect the health care worker from overt and covert exposure. The device will also serve to protect the reasable cuff from soiling and thus prolony the life of the reusable ouff.
The entire goneral patient population will be impacted with the use of the Cuff Saver. Health care workers will be impacted as well. Dirty blood prossure cuffs should no longer be a problem as, once cleaned, the Cuff Saver will protect blood pressure cuffs and cull bladders from further contamination By using the Cuff Savor in combination with the inflation bladder as the cuff, cleanliness can he assured because the Cuff Saver can be discarded and the bladder can be casily cleaned due to it's non porous surface. The older unsanitary reusable cuffs that employ Velcro as their fastenings are impossible to clean and retain all sorts of sufface material and contaminates. CulT Savers do not use Velero as a tastening, Instead, a very strong double sided adhesive tape is used to attach the culf surfaces to each other. No adhesive is in contact with the patients skin.
Since it has heen shown in the current medical literature that standard blood pressure cullis hubor pathogens, it follows that the Camoutlage Cutl Saver should and will be of great benefit in protecting the patient and the health care worker form pathogens. It should also be of the prevention of transference of disease and nosocomial infection In light of these potential health henchis to the goneral public, we request that Camouflage Cuff Savers be considered for Expedited Review.
10-7
Determination of Substantial Equivalence and Testing Summary:
Basically, the Camonflage Cull Saver is a disposable blood pressure cuff designed to be used in conjunction with a rensable cuff or commercially available inflation bag/bladder. When applied to the reusable cuff, it does not alter the performance of said cuff, you it protects the cuff from contamination and soiling. When used with the inflation bladder, it functions as a disposable cuff itself and verforms as well as a standard cuff. Clinical tests performed by N. A. Bragge Medical, Inc. on seventeen hyman volunteers of various sizes and upper arm circumference provide credible proof. Tests were performed with standard sizes of commercially available blood pressure coffs of both the reusable und disposable varieties. Culls of the bladder type and the bladderless
4
10-7 (continued)
type were tested with and without the application of the Camoutlage Cuff Saver device. The Cuff Saver was also tested with the standard commercially available intlation bladder with the Cull Saver covering the bladder and the Cuff Saver acting as the Cuff itself. Each subjects pressure was taken in the order listed with a three minute waiting period between each measurement. The pressures were taken using a Dinamap Brand noninvasive blood pressure machine. Measurement accuracy was confirmed by chocking the Dinamap machine against pressure laken with a calibrated mercury sphygmomanometer. For accuracy, cuffs used on each volunteer were at least 40% as wide as the circumference of the subjects upper arm. All subjects were awake and in an unaltered state of awareness during the testing.
The finding of the testing process showed no discornible or appreciable: difference between the blood pressures taken with the conventional blood pressure cuffs and those fitted with the Camountage Cuff Saver device. There was also no appreciable or discernible difference between the blood pressures taken with the conventional cull and those taken with the Camoullage Cull Saver fitted with the standard intlation bladder. All of the messurements obtained to the data acceptance limits set forth in the testing protocol and all results conformed to the puss frail criteria of a 95% Contidence interval of 4.3 or less derived from data collected from measuryment of blood pressure taken with the callbrated Dinaman brand blood pressure machine and the two industry standard culls used in the study. Minor fluctuations in the results obtained are attributed to the dynamic state of blood flow within the cardiovascular system and are physiologic in nulure. In conclusion, Camouflage Cuff Savers offer the public a functional, incxponsive alternative to the carrent disposables on the market today and provide a public health benefit to the general population by reducing the incidence of cross-contamination.
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) )
5
Safety and Effectiveness- Information contained in the body of the notification accompanying this summary provides biocompatibility data for the materials used in the construction of this device. Materials consist of DuPont Somara FRO2 nonwoven fiber( 55% polycolor, 45% wood pulp ), and 3M brand No. 9890 Double Coated Medical tape on a liner. Both products are biocompatible according to the test information supplied by the respective companies. Both products are already in use in the medical industry. Ink information is also supplied in the body of the notification and complies with national industry standards. Elfectiveness of the device is confirmed by statistical analysis of data contained in the Investigational Study located in the body of this 510(k) notification. Study data indicated that the Camouflage Cuff Saver can functional safely as a blood pressure cuff or as a cuff cover. Slight variations in the readings are physiologic and represent the dynamic state of the cardiovascular system. In a study conducted by Martin G. Myers, M.D., protecting culls during patient contact resulted in a marked and rapid decrease in the infection rate.(1) Reinforcing this literature is the small culture study performed in a working operating room by this company. In our sludy, the cuff that was protected with our device during patient contact produced "no growth 48 hrs" and a 0 colony count. This was not the casc with the unprotected cuffs which all grew bacteria. The world wide web was throughly searched for information pertaining to national or international standards for blood pressure cuffs. Apparently none exist. The F.D.A. has no performance standards for blood pressure cuffs. The American Heart Association was contacted for information periaining to cuff standards. There were no direct standards. Their recommendations for accurracy include monthly callbration of manual hume spygmomanometer units against an ancriod or mercury spygmomanometer and use of the correct size cuff to limb ratio (the cuff should be at least 40% as wide as the circumference of the limb to which it is applied). The Camouflage Cull Saver complies with these AHA recommendations.
(1)" . ongitudinal Evaluation of Neonatal Nosocomial Infections: Association of Infection with Blood Pressure Cuff," Martin G. Myers, M.D., Pediatrics, January 1978, 61, No. 1. p. 42-45.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Jacqueline Brackett CEO N.A. Braggs Medical, Inc. JUL 2 3 1997 1 8255 Brackett Lane ューーー Semmes, Alabama 36575
Re : K963987 Camouflaqe Cuff Savers Regulatory Class: II (Two) Product Code: 74 (DXQ) Dated: April 25, 1997 Received: May 1, 1997
Dear Ms. Brackett:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act), 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
7
Page 2 - Ms. Jacqueline Brackett
This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
870.1120 JSQ II - Blood Pressure Co. At
510(k) Number (if known): __ k 96 3987
Device Name: Camous Lage
Indications For Use:
The intended use of the Cuff Saver will be to cover all types of blood pressure cuffs and/or cuff bladders prior all types of brood pressure carr applied to the patient. Ehis to the cult of cull blauder being appear as a morker from overt
will protect the patient and the carest since blood pressure will protect the pactent and one noalsminated blood pressure cuffs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Berre R. Lamperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)