(315 days)
041894
Not Found
No
The 510(k) summary describes a physical medical device (needle and suture) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a needle and suture for tissue approximation, which is a surgical tool, not a therapeutic device. A therapeutic device is typically one that treats a disease or condition, often through non-surgical means or by delivering a specific therapy.
No
Explanation: The device description states its intended use is for "soft tissue approximation," which is a treatment, not a diagnostic, function.
No
The device description explicitly states it consists of a stainless steel needle and poly(ethylene terephthalate) suture, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the MANI Needle & Suture Pack consists of a needle and suture material. These are physical tools used for surgical procedures (tissue approximation).
- Intended Use: The intended use is for "short term soft tissue approximation," which is a surgical function, not a diagnostic test performed on a sample.
This device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GDL
Device Description
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) consists of a stainless steel needle and poly(ethylene terephthalate) suture, for use in short term tissue approximation, including use in ophthalmic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
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)
Not Found
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.
CP Medical, Orthofiber, 510(k) # 041894;
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.
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K050150
page 1 of 2
soft
DEC 5 2005
510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc.
This 510(k) summary of safety and effectiveness for the MANI Needle and Suture Pack (Poly(ethylene terephthalate)) is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | MANI, Inc. |
|---|---|
| Address: | 743 Nakaakutsu Takanezawa-Machi |
| Tochigi 329-1234 Japan (Headquarters) | |
| Contact Person: | David J. Bloch |
| Regulatory Counsel | |
| Telephone: | (202) 414-9209 (telephone) |
| (202) 414-9209 (fax) | |
| Preparation Date: | January 2005 |
| Device Trade Name: | MANI Needle and Suture Pack (Poly(ethylene |
| terephthalate)) | |
| Common Name: | Guide Needle, Surgical; Non- |
| Absorbable Suture, Poly(ethylene terephthalate). | |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493) |
| Non-Absorbable Suture, Poly(ethylene terephthalate) | |
| (21 C.F.R. § 878.5000) | |
| Product Code: GAT | |
| Predicate Devices: | CP Medical, Orthofiber, 510(k) # 041894; |
| Device Description: | The MANI Needle & Suture Pack (Poly(ethylene |
| terephthalate)) consists of a stainless steel needle and | |
| poly(ethylene terephthalate) suture, for use in short term | |
| tissue approximation, including use in ophthalmic surgery. |
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K050/50
page 292
The MANI Needle & Suture Pack (Poly(ethylene Intended Use: terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.
Based on the foregoing and other information in this CONCLUSIONS: application, MANI, Inc. believes that the MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is substantially equivalent to its claimed predicates under conditions of intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, a traditional symbol of medicine, with three parallel lines forming a wing-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 5
Mani, Inc. c/o David J. Bloch, Esq. Regulatory Counsel Reed Smith, LLP 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005-3373
Re: K050150
Trade/Device Name: MANI Needle & Suture Pack (Poly(ethylene terephthalate)) Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDL Dated: November 9, 2005 Received: November 9, 2005
Dear Mr. Bloch:
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.
3
Page 2- David J. Bloch, Esq.
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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely vours
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 1
Indications for Use
Kosol 50 510(k) Number (if known):
Device Name: MAN! Needle & Suture Pack (Poly(ethylene terephthalate))
Indications For Use:
The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for The MANI Needle & Suture Fack (F Sty(Stryton) Corp.
use in short term soft tissue approximation, including use in ophthalmic surgery.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchund
al, Restorative. and Neurological Devices
51000 Number K050150