(60 days)
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No
The summary describes a traditional surgical suture and does not mention any AI or ML components or functionalities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a suture, used for approximation or ligation of tissue, which is a supportive rather than therapeutic function.
No
Explanation: The device is a non-absorbable synthetic polyamide suture, which is used for soft tissue approximation and ligation during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly states it is a non-absorbable suture made of nylon yarns, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed on the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The device is a suture, a physical material used to close wounds or tie off blood vessels. This is a surgical tool, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, Sutralon nonabsorbable synthetic polyamide suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAR
Device Description
This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications.
Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.
The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
general soft tissue, cardiovascular, ophthalmic, neurological
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To establish the technical equivalency of SutraTec nylon nonabsorbable sutures with the predicate devices, tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted for diameter, tensile strength and sutureneedle attachment.
The test results shows that SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Ethicon nonabsorbable synthetic polyamide sutures.
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.
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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).
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§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
K99 4176
SutraTec, Inc. 8726 53nd Place, East Bradenton, Florida 34202
510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Applicant:
SutraTec, Inc. 8726 53ª Place, East Bradenton, Florida 34202 Mr. Joseph B. Gross, CEO Tel: (941) 727- 2434
Contact:
Jonathan Green Attorney-at-Law Corporate Secretary, SutraTec 4740 Connecticut Avenue, N.W. Suite 708 Washington D.C. 20008 Tel: (202) 966-3790
Date of 510(k) summary preparation: December 8, 1999
Trade name: Sutralon
Common name: Suture, nonabsorbable, synthetic polyamide
Predicate devices:
Sutralon nonabsorbable synthetic polyamide sutures manufactured by SutraTec, Inc. are equivalent to Ethicon nonabsorbable synthetic polyamide sutures.
Device Description:
This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications.
Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.
The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.
1
Intended use:
Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general
soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Performance tests to demonstrate substantial equivalency:
To establish the technical equivalency of SutraTec nylon nonabsorbable sutures with the predicate devices, tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted for diameter, tensile strength and sutureneedle attachment.
The test results shows that SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested.
Jonathan Greer
Jonathan Green, Corporate Secretary, SutraTec
Dec. 9, 1999
Date
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three lines forming its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 2000 FEB
SutraTec. Inc. c/o Mr. Jonathan Green 4740 Connecticut Avenue, N.W., Suite 708 Washington, D.C. 20008
Re: K994176 Trade Name: Sutralon Nylon Sutures Regulatory Class: II Product Code: GAR Dated: December 9, 1999 Received: December 10, 1999
Dear Mr. Green:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- The Sutralon Nylon Surgical Suture is indicated for use in general soft tissue 1 . approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
-
- This device may not be manufactured from any long chain aliphatic polymers other than nylon 6 and/or nylon 6,6. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Sutralon Nylon surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
3
Page 2 – Mr. Jonathan Green
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR). Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours,
Neil P. Ogden
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
Sutralon is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
MRO ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻡ ﺍﻟﻤﺴﺘﺨﺪﻣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ન્દ્ર દિવ્યુ (Division Sign-Off) Division of General Restorative Devices Kagula 510(k) Number_
Prescription Use __YES
(Per 21 CFR 801.109)