(113 days)
No
The document describes a mechanical suture delivery device and suture cartridges, with no mention of AI or ML capabilities.
No
The device is described as a delivery device intended to deliver a suture to an operative site and assists in suturing, suture ligation, and knot-tying. Its purpose is to facilitate consistent suture placement, not to directly treat a disease or condition.
No
The device is intended to deliver sutures and assist in suturing, not to diagnose medical conditions or diseases.
No
The device description clearly states it is composed of a "delivery device and suture cartridge," which are physical, hardware components. The summary also details testing related to these physical components and the suture material.
Based on the provided information, the Digitex Delivery Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver a suture to the operative site" and assist in "suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture." This describes a surgical tool used directly on tissue within the body.
- Device Description: The description details a "delivery device and suture cartridge" designed to "facilitate the consistent placement of suture." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Digitex Delivery Device does not perform any such analysis of bodily specimens.
Therefore, the Digitex Delivery Device is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.
The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.
Product codes
NEW,GAM
Device Description
The Digitex SDS is composed of delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the delivery device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location. The suture cartridges are provided pre-loaded with non-absorbable polypropylene, absorbable polydioxanone, or absorbable polyglycolic acid coated suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
The modifications to the Digitex Suture Cartridges, specifically, adding suture cartridges with polydioxanone and polyglycolic acid coated absorbable suture, were evaluated via design verification testing and simulated use tests in a cadaveric laboratory. These tests confirmed that the Digitex Suture Cartridges, as modified, meet the established design specifications and are substantially equivalent to the predicate polypropylene Digitex Suture Cartridges. The predicate Digitex Suture Cartridges were subjected to biocompatibility testing to support the original 510k (K093112) and acceptable results from this testing apply to the proposed absorbable Digitex Suture Cartridges; additional evaluation and testing was conducted and acceptable results from this testing further demonstrate the acceptable biocompatibility profile of the proposed absorbable Digitex Suture Cartridges. The sterilization method and sterility assurance lever (SAL) have not changed; the change to the contract sterilization facility and modified sterile barrier have been evaluated and meet the requirements of ISO 11135 and ISO 10993-7.
Key Metrics
Not Found
Predicate Device(s)
K093112, K930738, K030212, K991191, K992088
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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
7. 510(K) SUMMARY
MAY 2 3 2012
| 510(k) Owner/Submitter | Coloplast A/S; Division: Coloplast Corp
Holtedam 1, Humlebaek 3050 - Denmark
FDA Establishment Registration Number: 2125050 |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Janell A. Colley
Coloplast Corp
1601 West River Road North
Minneapolis, Minnesota 55411 USA |
| Date Prepared | 30 January 2012 |
| Common name/
Classification
(current/proposed) | Delivery Device: surgical instrument, 878.4800, Instrument, ligature passing and knot
tying
Current Suture Cartridge: surgical suture, 878.5010; Nonabsorbable polypropylene
surgical suture
Proposed Suture Cartridge |
| Proprietary Name | Digitex Suture Delivery System (SDS); Digitex Delivery Device, Digitex Suture
Cartridge |
| Predicate Devices | Digitex System: Digitex Suture Delivery System: K093112
Proposed Digitex Suture Cartridge predicates: Deknatel Deklene II suture, K930738;
Monodek PDO suture, K030212; Bondek PGA suture, K991191 & K992088 |
| Device Description | The Digitex SDS is composed of delivery device and suture cartridge and is designed for use by the physician to
facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical
location is difficult to reach. The shaft of the delivery device has been designed to allow for adjusting the angle of
the needle housing to further facilitate suture placement in the desired location. The suture cartridges are
provided pre-loaded with non-absorbable polypropylene, absorbable polydioxanone, or absorbable polyglycolic
acid coated suture. |
| Intended Use | The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The
device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-
tying by holding the suture.
The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation. |
| Technological Characteristics Compared to Predicate | The Digitex Suture Delivery System has the same intended use and fundamental scientific technology as the
predicates Digitex Suture Delivery System: K093112, Deknatel Deklene II suture, K930738; Monodek PDO suture,
K030212; and Bondek PGA suture, K991191 & K992088. |
| Summary Of The Nonclinical Tests Submitted | The modifications to the Digitex Suture Cartridges, specifically, adding suture cartridges with polydioxanone and
polyglycolic acid coated absorbable suture, were evaluated via design verification testing and simulated use tests in
a cadaveric laboratory. These tests confirmed that the Digitex Suture Cartridges, as modified, meet the established
design specifications and are substantially equivalent to the predicate polypropylene Digitex Suture Cartridges. The
predicate Digitex Suture Cartridges were subjected to biocompatibility testing to support the original 510k (K093112)
and acceptable results from this testing apply to the proposed absorbable Digitex Suture Cartridges; additional
evaluation and testing was conducted and acceptable results from this testing further demonstrate the acceptable
biocompatibility profile of the proposed absorbable Digitex Suture Cartridges. The sterilization method and sterility
assurance lever (SAL) have not changed; the change to the contract sterilization facility and modified sterile barrier
have been evaluated and meet the requirements of ISO 11135 and ISO 10993-7. |
| Summary Of Clinical Tests Submitted (As Applicable) | Not applicable |
Conclusions Drawn From The Nonclinical Tests The Digitex Suture Delivery System is substantially equivalent to the predicates.
ાં જ
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 consists of a stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S % Ms. Janell Colley Regulatory Affairs Manager 1601 West River Road North Minneapolis, Minnesota 55411
2 3 2012
Re: K120284
Trade/Device Name: Digitex Suture Delivery System (SDS) Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: NEW,GAM Dated: April 20 . 2012 Received: April 23, 2012
Dear Ms. Colley
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
2
Page 2 - Ms. Janell Colley
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
3
6. STATEMENT OF INDICATIONS FOR USE .
510(k) Number (if known): K120284
Device Name: Digitex Suture Delivery System (SDS)
Indications for Use:
The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.
The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120284
Coloplast Digitex Suture Delivery System Traditional 510(k) Digitex Absorbable Suture Cartridges Page 23 of 315