(90 days)
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No
The summary describes a simple textile product for orthopedic casting and contains no mention of AI, ML, or related concepts like image processing or performance studies based on data analysis.
No
Explanation: This device is described as a "tubular textile" used as a protective layer for orthopedic casts. Its function is mechanical support and protection, not therapeutic treatment of a condition or disease.
No
Explanation: The device is described as a tubular textile used as a protective layer for orthopedic casts. Its function is physical protection and support, not diagnosis.
No
The device is described as a "tubular textile" and "polyester material," indicating it is a physical product, not software.
Based on the provided information, the Clinitex® Stockinette is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly described as a "tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape." This is a physical support and protective function applied externally to the body.
- Device Description: The description reinforces its use as a textile for orthopedic casts.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Clinitex® Stockinette does not interact with or analyze any biological specimens.
- No Mention of Biological Analysis: The description focuses on the physical properties of the material (polyester, water repellent, rapid drying) and its role in a cast, not on any biological or chemical analysis.
Therefore, the Clinitex® Stockinette falls under the category of a medical device, but specifically one used for external support and protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material help repel water and dry rapidly.
Product codes
LGF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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 Regulatory Class: I Product Code: LGF September 9, 1997 Dated: September 10, 1997 Received:
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 requlations affecting your devices 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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 hot arress any obe Act for devices under the Electronic chrough 542 or the not roll 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 regulation (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Cellia 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: K973417
Device Name: Clinitex Stockinette
Indications For Use: Clinitex® Stockinette is a tubular textile used to form the first protective layer (base) of an orthopedic cast below the cast padding and cast tape. The polyester material 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)
Division Sign-Off
(Divisi eneral Restorative Dev 510(k) Num
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)