(90 days)
Not Found
No
The description focuses on the material composition and intended use of a wound dressing, with no mention of AI or ML technology.
No
The device is a wound dressing that aids in healing by controlling bleeding, drainage, and debridement, but it does not directly treat a disease or condition itself.
No
Explanation: The device is described as a wound dressing for packing wounds, controlling bleeding, encouraging drainage, and assisting in necrotic tissue removal. These are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a physical wound dressing made of cotton gauze impregnated with a solution. It is a tangible, hardware-based medical device.
Based on the provided information, the Kendall Curity Iodoform Packing Strip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for packing deep wounds, controlling bleeding, encouraging drainage, and assisting in removing necrotic tissue. These are all actions performed directly on or within the body for therapeutic purposes.
- Device Description: The device is a wound dressing (cotton gauze strip impregnated with a solution). This is a topical or internal medical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the body to provide information about a person's health status, diagnose a condition, or monitor treatment.
IVDs are devices used to perform tests on specimens taken from the human body. The Kendall Curity Iodoform Packing Strip is a therapeutic device used for wound management.
N/A
Intended Use / Indications for Use
The Kendall Curity Iodoform Packing Strip is intended for wet to dry packing of deep wounds including nasal and sinus passages. It helps control/prevent bleeding, encourages drainage and assists in removing necrotic tissue.
Product codes
EFO
Device Description
The proposed Kendall Curity lodoform Packing Strip is a sterile, single-use, wound dressing consisting of a cotton gauze strip impregnated with a formulated lodoform solution. It is packaged in HDPE amber colored bottles and is available in 14" x 5yd, 1/2" x 5yd, 1" x 5yd and 2" x 5yd sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
deep wounds including nasal and sinus passages
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Johnson & Johnson Medical, Inc., NU Gauze® lodoform Packing Strip
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 973763
EXHIBIT #6
510(k) Summary
DEC 3 1 1897
1
Kendall Curity lodoform Packing Strip
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Kendall Healthcare Products Company 15 Hampshire Street Mansfield. MA 02048 Date Prepared: September 24, 1997
Contact Person 1.
David A. Olson Manager Regulatory Affairs (508) 261-8530
2. Name of Medical Device
Classification Name: Common or Usual Name: Unclassified lodoform Packing Strip
3. Identification of Legally Marketed Device
The proposed Kendall Curity lodoform Packing Strip is substantially equivalent in intended use and composition to the Johnson & Johnson Medical, Inc., NU Gauze® lodoform Packing Strip which was in commercial distribution before May 28, 1976.
4. Device Description
The proposed Kendall Curity lodoform Packing Strip is a sterile, single-use, wound dressing consisting of a cotton gauze strip impregnated with a formulated lodoform solution. It is packaged in HDPE amber colored bottles and is available in 14" x 5yd, 1/2" x 5yd, 1" x 5yd and 2" x 5yd sizes.
ട്. Device Intended Use
The Kendall Curity lodoform Packing Strip is intended for wet to dry packing of deep wounds including nasal and sinus passages. It helps control/prevent bleeding, encourages drainage and assists in removing necrotic tissue.
1
4-2
Product Comparison 6.
The Kendall Curity Iodoform Packing Strip is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use.
7. Nonclinical Testing
Biocompatibility testing of the Kendall Curity lodoform Packing Strip has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
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Image /page/2/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is left-aligned and in a simple, sans-serif font. The image is a close-up of the address, with a horizontal line above the text.
Mr. David A. Olson Manager, Regulatory Affairs Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048
DEC 3 1 1997
Re: K973763 Kendall Curity Iodoform Packing Strip Regulatory Class: Unclassified Product Code: EFO Dated: October 1, 1997 Received: October 2, 1997
Dear Mr. Olson:
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, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual
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Page 2 - Mr. David A. Olson
registration, listing of devices, good manufacturing practices, 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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
This letter will allow you to begin 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) 594-4595. 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 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: KENDALL CURITY IODOFORM PACKING STRIP
Indications For Use:
It is indicated for general wound packing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division) | |
| Device: | DPS |
| 510(k) Number | K973763 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)