(49 days)
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Not Found
No
The summary describes a simple surgical kit for suture removal and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for suture removal procedures, which is a common medical procedure but does not directly treat a disease or condition to be considered therapeutic.
No
Explanation: The device is described as a "Suture Removal Kit" intended for "suture removal procedures." This indicates a therapeutic or procedural function, not a diagnostic one. Diagnostic devices are used to identify a disease or condition.
No
The 510(k) summary describes a "Suture Removal Kit," which is inherently a collection of physical tools used for a medical procedure. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the AMSINO® Suture Removal Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for use in suture removal procedures." This is a surgical or procedural use, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVD devices are used to perform tests in vitro (outside the body) on samples to gain information about a person's health. A suture removal kit is a tool used in vivo (on the body) to perform a physical procedure.
N/A
Intended Use / Indications for Use
The AMSINO® Suture Removal Kit is intended for use in suture removal procedures.
Product codes
MCZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
MAY - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs AMSINO International, Inc. 855 Towne Center Drive Pomona, California 91767
Re: K050656
Trade/Device Name: AMSINO® Suture Removal Kit Regulatory Class: Unclassified Product Code: MCZ Dated: February 20, 2005 Received: March 14, 2005
Dear Dr. Seah:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your 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 for use cated in to May 28, 1976, the enactment date of the Medical Device Amendments or 10 conimered prior to rial) 20, 2011 accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (the Act). You may, therefore, market the device, subject to the general and Cosmette Fiel (the Free However, you are responsible to determine that the medical devices controls promblems of reviews of reveals as a comment as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you to may 20, 1770, the components in bulk (i.e., unfinished) and further process (e.g., sterilize) purchase your do ree components in luding these components in your kit/tray. The general you must submit a new of the Act include requirements for annual registration, listing of devices, eontrols provisions or actice, 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 your device is elassinols. 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 I least of advised that I Drivies and a vour device complies with other requirements of the Act that IDA has made a acterimations administered by other Federal agencies. You must of any I cachar statutes and reguirements, including, but not limited to: registration and listing (21 Comply with an the Hot 871 CFR Part 801); good manufacturing practice requirements as set CITY Far 807), adeinig (21 OFR Part 820), and if applicable, the electronic form in the quality systems (QD) rogania (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ching Ching Seah, Ph.D.
In addition, we have determined that your device kit contains PVP Prep Pad which is subject to regulation as drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing we recomments for a drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research ﯩﭗ Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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.
Sincercly yours,
Eichler
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Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ansino International, Inc. 855 Towne Center Drive
Pornona CA 91767, USA Tel: (909) 626-5888 Fax: (909) 626-9006 Toll Free: 1-800-63-amsino c-mail: ansino@anisino.com ww.amsino.com
AMSINO
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| Indications for Use Statement |
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| ------------------------------- |
| 510(k) Number: (if known) | K050656 |
|---|---|
| Device Name: | AMSINO® Suture Removal Kit |
| Indications for Use: | The AMSINO® Suture Removal Kit is intended for use in suture removal procedures. |
Prescription X Use_ (Per 21 CFR 801. 109)
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Over-The-Counter Use___
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| vision of General, Restorative d Neurological Devices |