(141 days)
930517
Not Found
No
The 510(k) summary describes a physical medical device (needle and suture) and contains no mention of AI, ML, image processing, or any software-based analytical capabilities.
No.
The device is a needle and suture pack used for approximating soft tissue, which is a surgical tool, not a therapeutic device designed to treat a disease or condition.
No
The device is a needle and suture pack intended for tissue approximation, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of a stainless steel needle and Nylon suture, which are physical hardware components, not software.
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) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "Needle & Suture Pack (Nylon)" intended for "short term soft tissue approximation." This is a surgical tool used within the body to physically join tissues.
- Lack of Diagnostic Function: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information.
This device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MANI Needle & Suture Pack (Nylon) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAR
Device Description
The MANI Needle & Suture Pack (Nylon) consists of a stainless steel needle and Nylon suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Ophthalmic. Not for use in cardiovascular and neurological 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.
Alcon Laboratories, Surgical Suture, 510(k) # 930517.
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
§ 878.5020 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.
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K053637
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: 上一篇:
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 (Nylon) 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 (Nylon) |
| Common Name: | Guide Needle, Surgical; Non- |
| Absorbable Suture, Nylon. | |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493) |
| Non-Absorbable Suture, Nylon | |
| (21 C.F.R. § 878.5020) | |
| Product Code: GAR | |
| Predicate Devices: | Alcon Laboratories, Surgical Suture, 510(k) # 930517. |
| Device Description: | The MANI Needle & Suture Pack (Nylon) consists of a |
| stainless steel needle and Nylon suture, for use in short term | |
| soft tissue approximation, including use in ophthalmic | |
| surgery, but not for use in cardiovascular and neurological | |
| tissue. |
... .. .. . . . . . .
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Intended Use:
CONCLUSIONS:
The MANI Needle & Suture Pack (Nylon) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Based on the foregoing and other information in this application, MANI, Inc. believes that the MANI Needle & Suture Pack (Nylon) is substantially equivalent to its claimed predicates under conditions of intended use.
・・・・・・
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2006
MANI, Inc. % ReedSmith Mr. David J. Bloch, Esq. 1301 K. Street, NW Suite 1100 - East Tower Washington, District of Columbia 20005-3373
Re: K053637
Trade/Device Name: MANI Needle & Suture Pack (Nylon) Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: April 24, 2006 Received: April 26, 2006
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
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Page 2 - Mr. David J. Bloch, Esq.
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. 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/dsma/dsmamain.html
Sincerely yours,
Hubert Remmers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
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保障の原因を家庭和社会
510(k) Number (if known):
Device Name: MANI Needle & Suture Pack (Nylon)
Indications For Use:
The station of the state of the state of the states of the states and the
The MANI Needle & Suture Pack (Nylon) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
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)
Helmut Lerner
Division of General, Restorative. and Neurological Devices
Kos3677 510(k) Number_