(90 days)
Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast. This protective pad protects the skin, ensures that bony prominences are adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.
Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic cast.
The provided text is a 510(k) premarket notification letter from the FDA to Clinitex Medical Corporation regarding their Clinitex Stockinette and Clinitex Cast Padding devices.
This type of document is an approval letter for marketing medical devices based on the concept of "substantial equivalence" to devices already on the market prior to May 28, 1976. It does not contain information about:
- Acceptance criteria the device had to meet.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training sets.
The letter simply states that the FDA has reviewed the submission and found the devices to be substantially equivalent to predicates, thereby allowing them to be marketed, subject to general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the given input. The requested details are typically found in clinical study reports or performance validation sections of a 510(k) submission, not in the FDA's clearance letter itself.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Howell H. Michael General Manager Clinitex Medical Corporation 9801 Kincey Avenue, Suite 100 Huntersville, North Carolina 28078
Re : K973417 Clinitex® Stockinette K973420 Clinitex® Cast Padding Requlatory Class: I LGF Product Code: Dated: September 9, 1997 Received: September 10, 1997
Dear Mr. Michael:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
DEC - 9 1997
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Page 2 - Mr. Howell H. Michael
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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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 general 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.qov/cdrh/dsmamain.html".
Sincerely yours,
lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number: K973420
Device Name: Clinitex Cast Padding
Indications For Use: Clinitex Cast Padding is a thin mat of interlocked textile fibers used to form a protective pad of multiple layers between the stockinette and orthopedic This protective pad protects the skin, ensures that bony prominences are cast. adequately padded to prevent undesired pressure and/or chafing from the cast and compensates for normal amounts of swelling to the affected area immediately after the injury. The polyester fibers help repel water and dry rapidly.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
cdellep
(Division) Sign-Off) Division of General Restorative Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.5940 Cast component.
(a)
Identification. A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.(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 § 888.9. The device 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, regarding general requirements concerning records, and § 820.198, regarding complaint files.