(267 days)
Not Found
No
The device description focuses on the material composition and physical properties of the fabric, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use by patients with mild atopic dermatitis and has shown statistically significant improvements in the severity of atopic dermatitis.
No
The device is bedding intended for therapeutic use (to improve atopic dermatitis symptoms) rather than for diagnosing a condition.
No
The device is described as "Institutional Bedding made with DermaTherapy™ fabrics," which are physical textile products. The description details the fabric composition, weave, and treatments, indicating a hardware-based device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis." This describes a therapeutic or supportive use for a medical condition, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as "Institutional Bedding made with DermaTherapy™ fabrics." This is a physical product used externally, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- No mention of in vitro testing: The description focuses on the fabric properties, construction, and antimicrobial treatment. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This bedding does not fit that description.
N/A
Intended Use / Indications for Use
Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy™ fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.
Product codes
FMW
Device Description
The device that is the subject of this 510(k) premarket notification is generally described as Institutional Bedding made with DermaTherapy™ fabrics. Institutional bedding in this case refers to bed linens, generally comprised of a flat top sheet, a fitted or flat bottom sheet, and pillow cases that encase pillows on beds used in hospitals and/or in other healthcare or home settings.
DermaTherapy fabrics are plain-weave constructions of 100% contineous-filament yarns. The preferred embodiment of the technology involves 100% nylon yarns in one direction of the fabric, with 100% polyester yarns in the other direction. The polyester varns have a non-round fiber cross-section to create micro-channels to facilitate moisture wicking and rapid drying. The yarns used in DermaTherapy fabrics are commercially available products, typically used in women's lingerie or intimate apparel. Once woven, DermaTherapy fabrics are treated with a durable antimicrobial treatment to control bacteria and fungi growth on the fabrics. The antimicrobial treatment applied to DermaTherapy fabrics is a commercially available technology commonly used in the textile industry.
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
hospital, healthcare or home setting
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
Performance Testing: bench testing was performed and all tests showed satisfactory results. A clinical study was performed and included 37 subjects with mild atopic dermatitis. Results showed statistically significant improvements in the severity of atopic dermatitis, eczema, the level of itching, and perceived quality of life after eight weeks of using DermaTherapy bedding.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6190 Mattress cover for medical purposes.
(a)
Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
D.0 510(k) Summary of Safety and Effectiveness
D.1 Submitter Informațion
Company Name and Address:
JAN 2 5 2007
Precision Fabrics Group, Inc. 301 North Elm Street, Suite 600 Greensboro, NC 27401
Contact Name:
Terry Montgomery, PhD, Vice President Telephone: (336) 510-8009 Facsimile: (336) 510-8003 E-mail: terry.montgomery@precisionfabrics.com
Date Prepared: May 2, 2006
D.2 Name of Device
- 2.1 Trade Name: Institutional Bedding made with DermaTherapy™ fabrics
- 2.2 Common Name: DermaTherapyTM bed linens
- 2.3 Classification Name: Mattress Cover for Medical Purposes (21 CFR 880.6190); Product Code FMW
D.3 Substantial Equivalence Claimed to Predicate Devices
Allergy Control Cover, K903382
D.4 Device Description
The device that is the subject of this 510(k) premarket notification is generally described as Institutional Bedding made with DermaTherapy™ fabrics. Institutional bedding in this case refers to bed linens, generally comprised of a flat top sheet, a fitted or flat bottom sheet, and pillow cases that encase pillows on beds used in hospitals and/or in other healthcare or home settings.
DermaTherapy fabrics are plain-weave constructions of 100% contineous-filament yarns. The preferred embodiment of the technology involves 100% nylon yarns in one direction of the fabric, with 100% polyester yarns in the other direction. The polyester varns have a non-round fiber cross-section to create micro-channels to facilitate moisture wicking and rapid drying. The yarns used in DermaTherapy fabrics are commercially available products, typically used in women's lingerie or intimate apparel. Once woven, DermaTherapy fabrics are treated with a durable antimicrobial treatment to control bacteria and fungi growth on the fabrics. The antimicrobial treatment applied to DermaTherapy fabrics is a commercially available technology commonly used in the textile industry.
1
D.5 Intended Use
Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy™ fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.
D.6 Predicate Device Comparison of Indications for Use / Intended Use and Technical Characteristics
The comparison of the DermaTherapyTM fabrics was based on a review of the documentation for the device, relevant aspects of which are included in the company's 510(k) Premarket Notification, and information concerning the predicate device that was available to the company via public sources, i.e., Allergy Control Cover, K903382. The comparison considered material characteristics and the indications for use / intended use. Neither bench, animal nor clinical testing were assessed.
D.7 Performance Data
- Performance Standards (Section 514 Compliance): no applicable performance 7.1 standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act, for institutional bedding made with DermaTherapy™ fabrics. Institutional bedding made with DermaTherapy™ fabrics does conform with the FDA recognized standards for biocompatibility.
- Performance Testing: bench testing was performed and all tests showed satisfactory 7.2 results. A clinical study was performed and included 37 subjects with mild atopic dermatitis. Results showed statistically significant improvements in the severity of atopic dermatitis, eczema, the level of itching, and perceived quality of life after eight weeks of using DermaTherapy bedding.
D.8 Conclusion:
The information and data provided in this 510(k) Premarket Notification establish that Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy™ abrics is substantially equivalent to the afore-mentioned predicate device with respect to indications for use/intended use, and technical characteristics.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terry Montgomery, Ph.D. Vice President Precision Fabrics Group, Incorporated 301 North Elm Street, Suite 600 Greensboro, North Carolina 27401
JAN 2 5 2007
Re: K061242
Trade/Device Name: Institutional Bedding made with DermaTherapy™ Fabrics Regulation Number: 880.6190 Regulation Name: Mattress Cover for Medical Purposes Regulatory Class: I Product Code: FMW Dated: January 5, 2007 Received: January 8, 2007
Dear Dr. Montgomery:
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 - Dr. Montgomery
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Sujete Y. Michael DMD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4.0 - Indications for Use Statement
4.0 QDE Indications Statement
510(k) Number (if known): Unknown
Device Name: Institutional Bedding made with DermaTherapy™ Fabrics
Indications for Use: Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy™ fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.
Prescription Use: L (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: 12 (21 CFR 807 Subpart C)
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