(72 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use is a simple mechanical action.
No
The device is described as removing suture from the epidermis, which is a procedural task rather than a therapeutic treatment for a medical condition.
No
Explanation: The intended use of the device is "Removal of suture from the epidermis," which is a therapeutic or procedural action, not a diagnostic one.
No
The provided 510(k) summary describes a device for "Removal of suture from the epidermis." This is a physical action requiring a physical tool or instrument, not a software function. The summary lacks any mention of software, image processing, AI, or any other characteristics typically associated with a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Removal of suture from the epidermis." This is a physical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
IVDs are specifically designed to be used in vitro (outside the living organism) to examine specimens from the human body. This device's function is in vivo (within the living organism) or on the surface of the body.
N/A
Intended Use / Indications for Use
Removal of suture from the epidermis.
Product codes
GDY, GER, FRG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidermis
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
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.
2
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
3
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