(20 days)
No
The device is described as a convenience kit containing pre-packaged medical devices, with no mention of software, algorithms, or data processing.
No.
The document describes the device as a "convenience kit" of legally marketed devices, with its classification based on the highest-class device within it, identified as Class II. While Class II devices can be therapeutic, the document does not provide specific functional details of the kit's contents to confirm a therapeutic function. It focuses on packaging, sterilization, and stability, rather than therapeutic action.
No
The device is described as a 'convenience kit' that packages two or more finished medical devices together. Its purpose is to provide convenience to the user and is not described as performing any diagnostic function.
No
The device description explicitly states it is a "convenience kit" containing "two or more separate types of Ethicon finished devices" which are physical medical devices. The summary also details testing related to packaging, sterilization, and biocompatibility, all indicative of a physical product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a "convenience kit" containing pre-packaged medical devices for a procedure. There is no mention of testing samples (like blood, urine, tissue) outside of the body.
- Focus on surgical/procedural use: The description of the kit and its components suggests they are intended for use during a medical procedure, likely surgical, given the manufacturer (Ethicon, known for surgical products).
- Device classification: The highest classification is Class II, which is common for many medical devices used in procedures, but not specifically indicative of IVDs.
- Performance studies: The performance studies described (stability, biocompatibility, labeling, packaging, sterilization) are typical for medical devices intended for use in or on the body, not for IVDs which would focus on analytical and clinical performance related to diagnostic testing.
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device description does not align with that purpose.
N/A
Intended Use / Indications for Use
The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.
Product codes
GAM, GAQ, FZP, GAN, GAW, FTL, LDF
Device Description
Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II.
The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
Ethicon, Inc. followed its internal procedures for Design Control and performed the following design control activities for E-PACK™ Procedure Kits:
- Stability- Confirmed the stability of the E-PACK™ Procedure Kits and the individual products within the E-PACKTM Procedure Kits.
- Biocompatibility Confirmed that E-PACKTM Procedure Kits meet the ISO 10993-7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, requirements.
- Labeling Confirmed the E-PACK™ Procedure Kits meet labeling requirements for convenience kits.
- Packaging/Transit Testing Confirmed E-PACK™ Procedure Kit weight does not exceed the transit test worst case and the E-PACK™ components fit within the limits of the current packaging system. The proposed package configuration passed all transit testing requirements found in ISO 11607-1. Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- Sterilization- Confirmed that E-PACKTM Procedure Kit products can be sterilized with Ethylene Oxide and can be sterilized two times.
The safety and effectiveness of the modified E-PACK™ procedure kits and the substantial equivalence to the predicate device have been demonstrated via data collected during design verification. The results of these tests provide reasonable assurance that the modified device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. The modified package configuration used for the proposed device meets the requirements ISO 14971:2007 Medical devices --Application of risk management to medical devices and ISO 11607-1: 2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2016
Ethicon, Inc. Ms. Enza Deserio Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K161726 Trade/Device Name: E-PACKTM Procedure Kit Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, GAQ, FZP, GAN, GAW, FTL, LDF Dated: June 20, 2016 Received: June 22, 2016
Dear Ms. Deserio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161726
Device Name E-PACK™ Procedure Kit
Indications for Use (Describe)
The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
k) Pre-Market Notification thicon, Inc.
Image /page/3/Picture/1 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font, with ",INC." in a smaller font to the right. Below the company name is the text "a Johnson & Johnson company" in a cursive font. The logo is simple and clean, with a focus on the company name.
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, NJ 08876-0151 |
| ------------ | --------------------------------------------------------------------------------------------------------- |
|---|
-
Contact Person: Enza Deserio Regulatory Affairs Specialist Ph: (908) 218-2662 Fax: (908) 218-2595 Email: Edeserio@its.jnj.com
Date Prepared: June 20, 2016 -
Device Trade Name: E-PACK™ Procedure Kit
II -
Device Common Name: Convenience Kit
Class: -
Classification Name: Absorbable poly (glycolide/l-lactide) surgical suture (21 CFR 878.4493) Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (21 CFR 878.4495) Clip, Implantable (21 CFR 878.4300) Suture, Absorbable, Synthetic (21 CFR 878.4830) Suture, Nonabsorbable, Synthetic, Polypropylene (21 CFR 878.5010) Mesh, Surgical, Polymeric (21 CFR 878.3300) Electrode, Pacemaker, Temporary (21 CFR 870.3680)
-
GAM, GAQ, FZP, GAN, GAW, FTL, LDF Product Code:
4
Predicate Device Information:
| Device | Company | Product
Code | 510(k)
Number |
|---------|---------------|-----------------|------------------|
| E-PACK™ | Ethicon, Inc. | GAM | K970317 |
Device Description:
Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II.
The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.
Indications For Use:
The modified E-PACK™ procedure kits are provided with the same package inserts with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.
Packaging:
The modified E-PACK™ packaging will consist of a rigid PETG Thermoform Blister with a Tyvek lid. The modified packaging will include a Plastic Organizer sleeve where the individual devices are placed. The Thermoform blister tray/Tyvek lid is placed in carton dispenser box. The Thermoform blister tray will come in three different sizes to accommodate the different sizes of E-PACK™ s (small, medium, and large). New products cleared through the 510(k) process will be available subsequently for inclusion in the E-PACK™. The 510(k) submissions for these products will state that they will be included in the appropriate E-PACK™.
Summary of Technological Characteristics and Performance Testing:
Ethicon, Inc. followed its internal procedures for Design Control and performed the following design control activities for E-PACK™ Procedure Kits:
- i. Stability- Confirmed the stability of the E-PACK™ Procedure Kits and the individual products within the E-PACKTM Procedure Kits.
- ii. Biocompatibility Confirmed that E-PACKTM Procedure Kits meet the ISO 10993-7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, requirements.
5
- iii. Labeling Confirmed the E-PACK™ Procedure Kits meet labeling requirements for convenience kits.
- iv. Packaging/Transit Testing Confirmed E-PACK™ Procedure Kit weight does not exceed the transit test worst case and the E-PACK™ components fit within the limits of the current packaging system. The proposed package configuration passed all transit testing requirements found in ISO 11607-1. Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- v. Sterilization- Confirmed that E-PACKTM Procedure Kit products can be sterilized with Ethylene Oxide and can be sterilized two times.
The safety and effectiveness of the modified E-PACK™ procedure kits and the substantial equivalence to the predicate device have been demonstrated via data collected during design verification. The results of these tests provide reasonable assurance that the modified device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. The modified package configuration used for the proposed device meets the requirements ISO 14971:2007 Medical devices --Application of risk management to medical devices and ISO 11607-1: 2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Summarv of Substantial Equivalence:
The proposed device, Ethicon, Inc. E-PACK™, is substantially equivalent to the predicate, Ethicon, Inc. E-PACK™ in that they share:
- the same fundamental scientific technology,
- . the same intended use,
- . the same design.
- the same materials.
- . similar packaging materials,
- the same labeling components.
- . the same sterilization process (Ethylene Oxide),
- . the same sterility assurance level (SAL) is 10-6 and
- the same shelf life.
In summary, the proposed device, Ethicon. Inc. E-PACK™, is substantially equivalent to the predicate Ethicon, Inc. E-PACK™, as further demonstrated in Table 2, Section 12: Comparison of Proposed and Predicate Devices.
Conclusion:
Based on the intended use, technological characteristics, safety and performance testing, the modified package configuration of the proposed E-PACK™ has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate E-PACK™ (K970317).