(308 days)
Chromic Gut surgical sutures are indicated for use as absorbable sutures in gegeral soft tissue approximation and/or ligation, including use in ophthalmic procedures, out NOT for use in cardiovascular and neural tissue.
Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft Catgut plain surgical sutures are indicated of assessments of the subscribed on the researces, but NOT tissue approximation and neural tissue.
Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues.
Silk sutures are indicated for use as non-absorbable sutures in general soft tissues Silk sutures are indicated for use as non-acolorodolorouse in cardiovascular, ophthalmic, neural tissue.
Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue r oreximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue rylon battleoo and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Not Found
This documentation is a 510(k) premarket notification for various types of surgical sutures and needles. The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. This process does not involve establishing new acceptance criteria or conducting studies to demonstrate the device meets new performance standards in the same way a PMA (Premarket Approval) would.
Instead, the "study" demonstrating the device meets "acceptance criteria" in this context is the submission and review of information to establish substantial equivalence to a predicate device. The "acceptance criteria" are not reported device performance metrics against specific targets, but rather the FDA's regulatory requirements for demonstrating this substantial equivalence.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations inherent in a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety and effectiveness. There isn't a table of quantitative performance metrics with "reported device performance" against explicit thresholds in the way a PMA clinical trial would present.
Instead, the performance is implicitly compared to the predicate device's established safety and effectiveness. The document lists the general indications for use for each suture type, which functionally serve as the "performance" demonstrated to be equivalent to the predicate.
| Suture Type | Indication For Use (Functionally "Device Performance") | "Acceptance Criteria" (Implicit for 510(k)) |
|---|---|---|
| K982646 Ailee Sutures and Ailee Needles (General) | General soft tissue approximation and/or ligation. | Substantial equivalence to legally marketed predicate devices. |
| Chromic Gut | Absorbable sutures in general soft tissue approximation and/or ligation, including ophthalmic procedures, but NOT for cardiovascular and neural tissue. | Substantial equivalence to legally marketed predicate (Chromic Gut) predicate devices for these indications. |
| Catgut plain | Absorbable sutures in general soft tissue approximation, but NOT for cardiovascular and neural tissue. (Minor wording differences from Chromic Gut but similar intent). | Substantial equivalence to legally marketed (Catgut Plain) predicate devices for these indications. |
| Polyglycolic acid sutures | Absorbable sutures in general soft tissue approximation and/or ligation, including ophthalmic procedures, but NOT for cardiovascular and neurological tissues. | Substantial equivalence to legally marketed (Polyglycolic acid) predicate devices for these indications. |
| Silk sutures | Non-absorbable sutures in general soft tissues, but NOT for cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Silk) predicate devices for these indications. |
| Polyester sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Polyester) predicate devices for these indications. |
| Nylon sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Nylon) predicate devices for these indications. |
| Polypropylene sutures | Non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. | Substantial equivalence to legally marketed (Polypropylene) predicate devices for these indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document, being an FDA 510(k) clearance letter, does not contain details about specific test sets, sample sizes, or data provenance from studies. A 510(k) submission primarily relies on comparisons to predicate devices and potentially presents bench testing or material characterization data to support substantial equivalence. It is not a clinical trial report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a 510(k) submission in the way you're describing for, for example, a diagnostic AI. The "ground truth" here is the prior regulatory clearance and established safety/effectiveness of the predicate devices. The experts involved are FDA reviewers (e.g., those in the Division of Surgical, Orthopedic and Restorative Devices) who evaluate the submitted information against regulatory standards. Their qualifications are their expertise in medical device regulation and the relevant medical fields.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There isn't a "test set" and a process of adjudicating findings from it in the context of this 510(k) clearance letter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is surgical sutures and needles, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a 510(k) is the legally marketed predicate device. The manufacturer demonstrated that their Ailee Sutures and Needles are "substantially equivalent" to existing, cleared sutures and needles. This equivalence is established through comparison of:
- Intended use
- Technological characteristics (e.g., material composition, dimensions, sterilization method, mechanical properties)
- Performance data (e.g., tensile strength, knot security, absorption profile for absorbable sutures, biocompatibility, sterility) to show they are at least as safe and effective as the predicate device, or that any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning/AI device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its head facing left and three lines extending from its body, representing feathers or wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
APR 2 9 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MYCO Medical Supplies, Inc. % Mr. Raji Juma 101 Rose Valley Woods Drive Cary, North Carolina 27513
Re: K982646
Trade/Device Name: Ailee Sutures and Ailee Needles Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, GAL, GAP, GAS, GAR, GAM, GAN, and GAO Dated: April 6, 1999 Received: April 6, 1999
Dear Mr. Juma:
This letter corrects our substantially equivalent letter of June 2, 1999.
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 (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.
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 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.
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Page 2 - Mr. Raji Juma
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Mark N. Mellerason
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Center for Devices and Radiological Health
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Page 1 of 1
510 (k) Number (if known): K982646
Device Name: Chromic Gut
Indication For Use:
Chromic Gut surgical sutures are indicated for use as absorbable sutures in gegeral soft tissue approximation and/or ligation, including use in ophthalmic procedures, out NOT for use in cardiovascular and neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K982646
510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✗
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
10/300/H202/A
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K982646
| Page 1 of 1 | Rﺎ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍে | ្រី អ៊ី6 | 300/HAQ2/403 | |
|---|---|---|---|---|
| 510 (k) Number (if known): K982646 | ﺃﺷﺎﺭﻪ ﻳﺴﺮ | 12 | ||
| Device Name: Catgut plain | ું છે. ગુજરાત રાજ્યના દિવસાય ખેતી, ખેત్లో గ్రా | 66. Hy Lt | onal | |
| Indication For Use: |
Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft Catgut plain surgical sutures are indicated of assessments of the subscribed on the researces, but NOT tissue approximation and neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Continued Collection of CORL Office Explugtion (ODE) RITE BELOW THIS LINE-CONTING of Device Evaluation (ODE)
Accevedo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K-982646
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
b
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Page 1 of 1
/ 300/ HAQOV
్రాన
510 (k) Number (if known): K982646
Device Name: Polyglycolic acid sutures
Indication For Use:
Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
BRL, Office of Device Evaluation (ODE),
(Division Sign-Off)
Division of General Restorative Devices K982646
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
sh
32
1
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Image /page/5/Picture/0 description: The image shows a document page with some text. The text includes "K982646" at the top left, "FDA/CDRH/ODE/OMC" vertically aligned on the right, and "APR 6 12 17 PH '99" also vertically aligned. The word "RECEIVED" is printed vertically, and the phrase "Page 1 of 1" is at the bottom left.
510 (k) Number (if known): K982646
Device Name: Silk sutures
Indication For Use:
Silk sutures are indicated for use as non-absorbable sutures in general soft tissues Silk sutures are indicated for use as non-acolorodolorouse in cardiovascular, ophthalmic, neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
THE CONSTITUTION OF CORPL Office Firelustion (ODE) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 1462646
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
{6}------------------------------------------------
1982646
| 510 (k) Number (if known): | K982646 |
|---|---|
| Device Name: | Polyester sutures |
| Indication For Use: |
Page 1 of 1
FDA/CDRH/ODE/DMC
APR 6 12 17 PM '99
RECEIVED
Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue r oreximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Otley
(Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices K982646
510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
റ
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1982646
| Page 1 of 1 |
|---|
| ------------- |
| 510 (k) Number (if known): | K982646 |
|---|---|
| Device Name: | Nylon sutures |
| Indication For Use: |
| FDA/CDRH/ODE/DMC | |
|---|---|
| APR 6 12 17 PM '99 | |
| RECEIVED |
Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue rylon battleoo and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eyaluation (ODE)
Páello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982646
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
{8}------------------------------------------------
14982646
| Page 1 of 1 | ri1ر | APP0 | ||
|---|---|---|---|---|
| 510 (k) Number (if known): K982646 | ﺃﺷﺎﺭﻙ ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | 12 | ||
| Device Name: Polyproylene sutures | 66. Hy LT | |||
| Indication For Use: | ో |
Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
billes
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982646
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
( (
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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.