AILEE SUTURES AND AILEE NEEDLES

K982646 · Myco Medical Supplies, Inc. · GAL · Jun 2, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K982646
• Device Name: AILEE SUTURES AND AILEE NEEDLES
• Applicant: Myco Medical Supplies, Inc.
• Product Code: GAL · General, Plastic Surgery
• Decision Date: Jun 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, but NOT for use in cardiovascular 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 and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue. Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue approximation 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.

Device Story

Ailee Sutures and Ailee Needles are surgical devices used for tissue approximation and ligation. The product line includes various materials: absorbable (Chromic Gut, Catgut plain, Polyglycolic acid) and non-absorbable (Silk, Polyester, Nylon, Polypropylene). These sutures are used by surgeons in clinical settings to close wounds or secure tissues. The device functions by physically holding tissue edges together to facilitate healing. The healthcare provider selects the appropriate suture material and needle based on the specific surgical procedure and tissue type. The device benefits patients by providing mechanical support to surgical sites, promoting effective wound closure, and reducing the risk of dehiscence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Suture materials include Chromic Gut, Catgut, Polyglycolic acid, Silk, Polyester, Nylon, and Polypropylene. Devices are provided as sterile sutures with needles. No specific ASTM standards or software algorithms are described.

Indications for Use

Indicated for general soft tissue approximation and/or ligation. Specific indications vary by material: Chromic Gut and Polyglycolic acid (ophthalmic, non-cardiovascular/neural); Silk, Polyester, Nylon, and Polypropylene (cardiovascular, ophthalmic, neural).

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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

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|------------------------------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------|
| 510 (k) Number (if known): K982646 | | ﺃﺷﺎﺭ<br>ﻪ ﻳﺴﺮ | 12 | |
| Device Name: Catgut plain | | ું છે. ગુજરાત રાજ્યના દિવસાય ખેતી, ખેત<br>్లో 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)

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#### 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)

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#### 14982646

| | Page 1 of 1 | ri<br>1<br>ر | APP<br>0 | |
|------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--|
| 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)

( (