(88 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a kit of legally marketed components.
No
The provided text does not contain any information about the device's function or purpose, only that it is a "procedural kit" and its components are "legally marketed devices." Without details on what the device does, it cannot be determined if it is therapeutic.
No
The provided text does not mention the device being used for diagnosis, but rather describes it as a convenience kit for surgeons containing legally marketed devices.
No
The 510(k) summary describes a "procedural kit" containing legally marketed devices, which are physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a "procedural kit" containing legally marketed devices for surgical use. There is no indication that the device is intended for testing samples (like blood, urine, or tissue) outside of the body.
- Intended Use: The intended use is described as being provided in a "procedure kit" for the convenience of the surgeon. This points towards a device used during a surgical procedure, not for diagnostic testing.
- Device Description: The components are described as "legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses." This suggests they are surgical instruments or supplies, not diagnostic reagents or equipment.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The description of this device does not align with this purpose.
N/A
Intended Use / Indications for Use
There is no change in the approved intended use of the device when provided in the procedure kit
Product codes
Not Found
Device Description
All components of E-PACK procedural kit are legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses. These products are packaged together in the form of a "kit" for the convenience of the surgeon.
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Predicate Device E-PACK Procedural Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
ा में बना दें कि रहा है।
सन्दर्भ सामग्री
बाहरी मानवास
मिसी मानवार
मिस्तार मिस्त मिसी
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| MODIFIED DEVICE NAME: E-PACK Procedural Kit | |
| PREDICATE DEVICE NAME: Predicate Device E-PACK Procedural Kit | |
| 510(k) SUMMARY | |
| Device Description | All components of E-PACK procedural kit are legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses. |
| These products are packaged together in the form of a "kit" for the convenience of the surgeon. | |
| Intended Use | There is no change in the approved intended use of the device when provided in the procedure kit |
Continued on next page
. '
Modified E-PACK Procedure Kit ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
| Sterilization | E-Pack procedural kits are sterilized by ethylene oxide for
minimum sterility level of 10-6. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging | The component devices in the E-PACK procedure kit may be
packaged in their current individual package or paper folders
into one large thermoformed blister tray or in a flexible
configuration consisting of a sealed pouch. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug, and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs and Quality Assurance
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | January 24, 1997 |
Modified E-PACK Procedure Kit ETHICON, Inc.
17
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