(72 days)
Removal of suture from the epidermis.
Not Found
The provided documents are 510(k) clearance letters from the FDA regarding "CPR Lap Sponges", "Basic Set-Up Tray", and "CPR Suture Removal Kit". These documents establish that the devices are substantially equivalent to devices marketed prior to May 28, 1976. This correspondence is primarily administrative and regulatory in nature.
There is no information in these documents about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to the technical performance of an AI/ML powered medical device.
The document dated April 9, 2024, is an administrative update to a previous 510(k) letter from March 28, 1996, indicating a re-categorization of the device technology under a new product code (GDY for Nonabsorbable gauze for internal use). It explicitly states, "Please note that the 510(k) submission was not re-reviewed."
The original 510(k) letter from March 28, 1996, makes a determination of substantial equivalence based on the devices being "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)." This indicates that the clearance was based on equivalence to predicate devices already on the market, not on a detailed performance study as would be required for a novel device, especially an AI/ML one.
Therefore, I cannot provide the requested information from these documents as they do not contain details about:
- A table of acceptance criteria and reported device performance
- Sample sizes or data provenance for test sets
- Number or qualifications of experts
- Adjudication method
- Multi-reader multi-case comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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April 9, 2024
Custom Pack Reliability Richard Ellwood President 4207 Vineland Road, M-1 Orlando, Florida 32811
Re: K960236
Trade/Device Name: CPR Lap Sponges Regulation Number: 21 CFR 878.4450 Regulation Name: Nonabsorbable gauze for internal use Regulatory Class: Class I Product Code: GDY
Dear Richard Ellwood:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 1996. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code GDY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, yu-chieh.chiu@fda.hhs.gov.
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard L. Ellwood President Custom Pack Reliability 4207 Vineland Road, M-1 Orlando, Florida 32811
MAR 2 8 1996
Re: K960236 Lap Sponges Requlatory Class: I Product Code: GER K960208 Basic Set-Up Tray K960238 CPR Suture Removal Kit Regulatory Class: II Product Code: FRG Dated: February 15, 1996 February 23, 1996 Received:
Dear Mr. Ellwood:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the 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 However, you are responsible to determine that of the Act. the medical devices you use as components in the Lap Sponges, Basic Set-Up Tray and CPR Suture Removal Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment If you date of the Medical Device Amendments. Please note: purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kits. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Mr. Richard L. Ellwood
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your devices in this response to your Please note: the Federal Register. premarket notification submissions 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 immediately will allow you to begin marketing your devices as described in your 510(k) premarket notifications. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market, but it does not mean that FDA approves your devices. Therefore, you may not promote or in any way represent your devices or their labeling as being approved by FDA. If you desire specific advice for your devices on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
Kimber C. Richter, M.D.
Acting Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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K960238 - Moren): Status (
Suture Removal Kit Device Name:
Indications For Use:
Removal of suture from the epidermis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ball
(Division Sign-Off) Division of Genera! Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
Over-The-Counter Use
§ 878.4450 Nonabsorbable gauze for internal use.
(a)
Identification. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.(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 § 878.9.