(9 days)
Not Found
No
The 510(k) summary describes a sterile, single-use kit containing pre-approved or exempt medical devices and drugs for minor surgical procedures. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The focus is on the convenience of the assembly of existing components.
No
Explanation: The device is a tray/kit containing medical products for minor surgical procedures, not a device that directly provides a therapeutic effect to a patient. Its primary purpose is convenience for the medical practitioner.
No
The document states that the device is "intended to be used by Healthcare professionals for minor surgical procedures." It is an assembly of medical products for convenience during surgical procedures, not for determining the nature or cause of a disease or condition.
No
The device is described as an assembly of physical medical products within a pouch, including medical devices and drugs. It is a sterile, single-use, disposable kit, clearly indicating it is a hardware-based product, not software-only.
Based on the provided information, the JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "minor surgical procedures" performed on patients, such as "dermological excisions or circumcisions." This involves direct interaction with the patient's body for a surgical purpose.
- Device Description: The device is an "assembly of medical products" used during a surgical procedure. It contains medical devices and drugs.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The description of the CareKits does not involve the analysis of such specimens.
The CareKits are clearly intended for use on the patient during a surgical procedure, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.
Product codes
79LRP
Device Description
The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable. The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis.
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
No clinical evaluations were completed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, 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 shows a series of handwritten alphanumeric characters. The characters are 'K961683' and are written in a bold, cursive style. The numbers and letters are connected, giving the impression of a single, continuous word.
MAY 10 1996
ATTACHMENT 1 Page 1 of 2
510(K) SUMMARY
JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit
Submitter Information:
JJ Skinner Inc. Stark Bldg. Suite 825 455 South Fourth Avenue Louisville, KY 40202
510(k) Summary Prepared By:
Carolann Kotula mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 (516) 482-9001
Date 510(k) Summary Prepared: April 25, 1996
Name of the Device:
| Trade or Proprietary Name: | JJ Skinner CareKits™ Minor Surgical
Procedure Tray |
|----------------------------|-------------------------------------------------------|
| Common Name: | Custom Minor Surgical Procedure Tray/Kit |
| Classification Name: | Tray, Surgical, General Product Code: 79LRP) |
DEVICE DESCRIPTION
The devices are an assembly of medical products within Tyvek®/polyethylene breather pouch. The medical products include medical devices, and drugs that are 510(k) approved devices, grandfathered, or exempt. The primary purpose of the assembly is for the convenience of the Medical practitioner. The kit is sterile, single use and disposable.
1
ATTACHMENT 1 Page 2 of 2
The kits are custom made for the customer, who specifies the name of the kit (i.e.) as well as the contents. Attachment 5 includes a list of the medical components that may be requrested by the customer.
Identification of Legally Marketed Device to Which Submitted Substantial Equivalence:
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is substantially equivalent in intended use and contents to trays legally marketed. Several companies including JJ Skinner's CareKits™ approved under K903545.
Intended Use of the Subject Devices:
The JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit is intended to be used by Healthcare professionals for minor surgical procedures. Minor surgical procedures are those generally performed on an outpatient basis, under topical anesthetics. These may include dermological excisions or circumcisions.
Technological Characteristics of the Subject Device:
The technological characteristics of JJ Skinner CareKits™ Minor Surgical Procedure Tray/Kit and the predicate device are substantially equivalent as supported by the comparison of similar significant features, components, and intended use.
No clinical evaluations were completed.