(141 days)
Not Found
No
The device description and intended use clearly define a physical needle and suture pack, with no mention of software, algorithms, or any technology that would incorporate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is a needle and suture pack used for surgical approximation of soft tissue. It is a surgical tool, not a device designed to directly treat or cure a disease or condition.
No
Explanation: The device description states its use is for "short term soft tissue approximation" and makes no mention of diagnosing conditions. It is a surgical tool, not a diagnostic one.
No
The device description explicitly states it consists of a stainless steel needle and silk suture, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "short term soft tissue approximation," which is a surgical procedure performed on the body.
- Device Description: The description confirms it's a "stainless steel needle and silk suture," which are surgical tools used in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, while this device is used directly on the body during surgery.
N/A
Intended Use / Indications for Use
The MANI Needle & Suture Pack (Silk) 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
GAP
Device Description
The MANI Needle & Suture Pack (Silk) consists of a stainless steel needle and silk 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
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)
Alcon Laboratories Needles and Sutures, 510(k) # 760158.
Reference Device(s)
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
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.
0
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 (Silk) 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 (Silk) |
| Common Name: | Guide Needle, Surgical; Non- |
| Absorbable Suture, Silk. | |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493) |
| Non-Absorbable Suture, Silk | |
| (21 C.F.R. § 878.5030) | |
| Product Code: GAP | |
| Predicate Devices: | Alcon Laboratories Needles and Sutures, 510(k) # 760158. |
| Device Description: | The MANI Needle & Suture Pack (Silk) consists of a |
| stainless steel needle and silk suture, for use in short term | |
| soft tissue approximation, including use in ophthalmic | |
| surgery, but not for use in cardiovascular and neurological | |
| tissue. | |
| Intended Use: | The MANI Needle & Suture Pack (Silk) is intended for use in |
| short term soft tissue approximation, including use in |
: 上一篇: 上一篇:
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ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
CONCLUSIONS: Based on the foregoing and other information in this application, MANI, Inc. believes that the MANI Needle & Suture Pack (Silk) 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 stylized human figure with outstretched arms, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the figure. The text is in all caps and is written in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2006
MANI, Inc. % ReedSmith Mr. David J. Bloch, Esq. 1301 K. Street, NW Suite 1100 - East Tower Washington, District of Columbia 20005-3373
Re: K053638
Trade/Device Name: MANI Needle & Suture Pack (Silk) Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP 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
3
Page 2 - Mr. David J. Bloch, Esq.
forth in the quality systems (OS) 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,
Mark N. Milliken
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
510(k) Number (if known):
Device Name: MANI Needle & Suture Pack (Silk)
Indications For Use:
大きなくている人気をなると、同時のためますが、
The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
the state the the production of the season of the state of the collection of the comments of
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)
Herbert Lemer no
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K053638