(91 days)
N18331
Not Found
No
The 510(k) summary describes a surgical suture and does not mention any AI or ML components or functionalities.
No.
The device is a surgical suture used for tissue approximation and ligation, not for treating a disease or condition.
No
The device is described as an absorbable suture used for general soft tissue approximation and/or ligation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "flexible monofilament suture thread," which is a physical, hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description: The description clearly states that this device is an "absorbable, flexible monofilament suture thread." Sutures are used inside the body to approximate and ligate tissues during surgical procedures.
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" and "paediatric cardiovascular surgery." These are surgical applications, not diagnostic tests performed on samples.
The information provided describes a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
MonoPlus Poly-p-dioxanone absorbable suture are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.
Product codes (comma separated list FDA assigned to the subject device)
79NEW, NEW
Device Description
The subject device is an absorbable, flexible monofilament suture thread which is supplied sterile. It is composed of a synthetic Poly (p-dioxanone), and it is indicated for soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue. It will be offered undeyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3602. It is available uncoated, and will be available with or without standard needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, paediatric cardiovascular surgery
Indicated Patient Age Range
pediatric (for cardiovascular surgery), adult (not for cardiovascular tissue)
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
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.
N18331
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.
0
KΦ312/6
Page 1 of 1
C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
[in Accordance with SMDA of 1990]
MonoPlus Poly-p-dioxanone absorbable suture
April 18, 2003
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller
800-258-1946 x 5073 (phone)
610-791-6882 (fax) |
| TRADE NAME: | MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture |
| COMMON NAME: | Synthetic Absorbable Surgical Suture |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 79NEW |
| CLASSIFICATION: | 878.4840 - Suture, surgical, absorbable , polydioxanone |
| REVIEW PANEL: | General & Plastic Surgery |
INDICATIONS FOR USE
MonoPlus Poly-p-dioxanone absorbable suture are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.
DEVICE DESCRIPTION
The subject device is an absorbable, flexible monofilament suture thread which is supplied sterile. It is composed of a synthetic Poly (p-dioxanone), and it is indicated for soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue. It will be offered undeyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3602. It is available uncoated, and will be available with or without standard needles attached.
PURPOSE FOR SUBMISSION
This submission seeks marketing clearance for Aesculap's MonoPlus Poly-p-dioxanone absorbable suture.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
Aesculap® Inc. believes that MonoPlus Poly-p-dioxanone monofilament absorbable surgical suture is substantially equivalent to:
- Ethicon, Inc.; PDS II Polydioxanone Suture (N18331) .
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUL 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K031216
Trade/Device Name: MonoPlus Poly-p-dioxanone absorbable suture Regulation Number: 21 CFR 878.4840 Regulation Name: Suture, surgical, absorbable, polydioxanone Regulatory Class: II Product Code: NEW Dated: April 16, 2003 Received: May 6, 2003
Dear Mr. Keller:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. Georg Keller
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
B. INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number:
φ3/2/6
Device Name:
MonoPlus Poly-p-dioxanone absorbable suture
Indication for Use:
MonoPlus Poly-p-dioxanone absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in pediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ or Over-the-C
(per 21 CFR 801.109)
or Over-the-Counter Use
Miriàm C. Provost
ral. Restorative and Neurological Dev
510(k) Number K031216