(73 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No.
The device is an absorbable surgical suture designed for soft tissue approximation. It is not used for diagnosis, cure, mitigation, treatment, or prevention of disease, which are characteristics of a therapeutic device.
No
This device is a surgical suture used for tissue approximation, not for diagnosing conditions.
No
The device description clearly states it is a physical surgical suture made of polyester, poly (p-dioxanone), and includes needles. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "surgical monofilament suture composed of polyester, poly (p-dioxanone)." This is a physical material used to close wounds or hold tissue together during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
IVDs are used to perform tests outside of the body on samples taken from the body to provide diagnostic information. This device is a surgical tool used within the body during a procedure.
N/A
Intended Use / Indications for Use
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue, pediatric cardiovascular tissue, ophthalmic. Not for use in adult cardiovascular, microsurgery and neural tissue.
Indicated Patient Age Range
Pediatric
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)
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 41.
No clinical trials were conducted.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 27, 2018
Demetech Corporation % Ms. Linda Hernandez Head of Quality 14175 NW 60th Ave Miami Lakes, Florida 33014
Re: K181582
Trade/Device Name: DemeTECH DemeDIOX absorbable surgical suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: June 12, 2018 Received: June 15, 2018
Dear Ms. Hernandez:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K181582
Device Name DemeDIOX Absorbable Surgical Suture
Indications for Use (Describe)
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tisue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for "DemeTECH". To the left of the company name is a circular logo with a triangle in the center. The triangle is light blue and the circle is a gradient of light blue. The company name is in bold, black font, and the registered trademark symbol is to the right of the company name.
006 - 510(K) Summary
This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of DemeTECH Sutures to those of the legally marked devices listed.
| A. Applicant: | DemeTECH Corporation,
14175 NW 60th Ave.
Miami Lakes FL. 33014 |
|---------------------------|----------------------------------------------------------------------|
| B. Contact Person: | Luis Arguello
Phone: 305-824-1048 Ext 113
luis@demetech.us |
| C. Date Summary Prepared: | June 12, 2018 |
| Trade Name: | DemeDIOX Absorbable Surgical Suture |
| Common Name: | POLYDIOXANONE monofilament synthetic
absorbable sutures Suture |
| Classification Name: | Absorbable expanded Polydioxanone
surgical suture |
| Product Code: | NEW
21 CFR 878.4840
Class II |
D. Predicate Device:
The predicate is the original DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE, 510K K082097.
E. Device Description:
DemeDIOX Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures and the modification from the existence 510k K082097 is that thread is winded around the needle, a foam needle park is applied to the needle to securely hold the needle in place with the thread. One to four needles will be placed in a suture size 6-0, 5cm length, no thread attached to the needle. The material is dyed violet or un-dyed and contains no additives.
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Image /page/4/Picture/0 description: The image contains the logo for DemeTECH. On the left side of the logo is a blue circle with a white triangle inside. To the right of the circle is the company name, "DemeTECH", in bold, black letters. A registered trademark symbol is located to the right of the company name.
F. Intended Use:
DemeDIOX Absorbable Surgical Suture is indicated for use in general soft tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
G. Non-Clinical Tests Performed:
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 41.
| Comparison Items | DemeDIOX Demetech
Absorbable Suture | Demetech Polydioxanone
Absorbable Suture |
|---------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Product Code | NEW | Same |
| Common Name | Polydioxanone Absorbable Suture | Same |
| Suture Characteristic | Absorbable Polydioxanone surgical
suture | Same |
| Labeling | Sterile, Single Use | Same |
| Intended Use | Soft tissue approximation | Same |
| Technical Characteristics | Monofilament, synthetic absorbable
suture is prepared from polyester, poly-
(p-dioxanone) | Same |
| Material | Prepared from polyester,
poly-(p-dioxanone) | Same |
| Sizes | 6-0 | 2-0, 3-0, 4-0, 5-0, 6-0 |
| Sterilization | Ethylene Oxide (EO) | Same |
| USP Performance
Requirements | Suture Material meets or exceeds
performance requirements for
"Absorbable Surgical Suture" in USP 40. | Same |
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Image /page/5/Picture/0 description: The image contains the logo for "DemeTECH". To the left of the company name is a blue circle with a white triangle inside. The company name is in bold, black font. To the right of the company name is the registered trademark symbol.
| Comparison Items | DemeDIOX Demetech
Absorbable Suture | Demetech Polydioxanone
Absorbable Suture |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength
Requirements | Length of the thread is too short to
perform the knot pull | Suture Material meets or
exceeds the performance
requirements defined in the USP
40 for "Tensile Strength" |
| Needle Attachment
Requirements | Thread is not attached to the needle | Suture Material meets or
exceeds the performance
requirements defined in the USP
40 for "Needle Attachment"
|
| Suture Length
Requirements | Suture Material meets or exceeds the
performance requirements defined in
USP for "Suture Length Requirement"
(95% of stated label length) | Same |
| Suture Packaging | Suture Material is packaged in a same or
equivalent manner with sterile single or
double package having labeling
conforming to 21 CFR and USP 40. | Same |
H. Clinical Tests Performed:
No clinical trials were conducted
l. Conclusion:
DemeDIOX Absorbable Surgical Suture is composed of the same material as the predicated device Demetech Polydioxanone Absorbable Suture and has the same design being a sterile, flexible, monofilament absorbable thread meeting all the requirements of the United States Pharmacopeia with the exception of the needle attachment and knot pull. DemeTECH's material used was selected based on known biocompatibility (per ISO 10993) and established history of use in the surgical suture industry.
The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of DemeTECH DemeDIOX Absorbable Surgical Suture to that of the predicate devices. It further demonstrates conformance with the USP, ISO 10993 and FDA Guidance for Surgical Suture 510(k).
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Image /page/6/Picture/1 description: The image shows the DemeTECH logo. The logo consists of a light blue triangle on the left and the word "DemeTECH" in black on the right. The triangle is a three-dimensional shape with a light blue color and a white outline. The word "DemeTECH" is in a bold, sans-serif font.
Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH DemeDIOX Absorbable Surgical Suture is substantially equivalent and are safe and effective for its intended purpose.