(52 days)
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens.
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.
The MedChannel OptiCLEAN Lens Irrigator is a single lumen endoscopic lens irrigator, designed for attachment to 10 mm diameter endoscopes. The irrigator comes in two sizes 285 mm or 305 mm, depending on surgeon's preference. The lens irrigator provides irrigation to the lens of an endoscope to prevent dimming and fogging of the lens during endoscopic surgical procedures.
The MedChannel OptiDOCK Tissue Ligator is a single use disposable suture passer, designed for use during endoscopic procedures. The OptiDOCK Tissue Ligator is pre loaded with PGA suture (USP 2-0).
The provided text is a 510(k) summary for the MedChannel OptiCLEAN Lens Irrigator and OptiDOCK Tissue Ligator. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, describing the intended use, and listing the standards achieved (such as ISO 10993 for biocompatibility and AAMI 11135 for sterilization). It outlines the regulatory classification and the FDA's decision to clear the devices for marketing based on substantial equivalence.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and the study proving it, as that information is not present in the provided text.
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AUG 1 5 2005
K051700
1/2
510(k) Summary of Safety and Effectiveness MedChannel Endoscopic Accessories Monday, May 23, 2005
Company Name
MedChannel, ILC 75 Federal Street, 9th Floor Boston, MA 02210
Official Contact
Frederick Tobia Regulatory Consultant
Device Name
| Proprietary Name: | MedChannel OptiCLEAN Lens Irrigator & OptiDOCK Tissue Ligator |
|---|---|
| Common Name: | Endoscopic Lens Irrigator/CleanerEndoscopic Suture Passer |
| Classification Name(s): | 21 CFR § 876.1500 Endoscope and Accessories21 CFR § 878.4493 Suture, absorbable, synthetic |
Predicate Devices used for Substantial Equivalence
| Endoscopic Anti Fog Device | Mectra Labs |
|---|---|
| Endoscopic Irrigation Channel | Byrne Medical |
| Endosuture Suture Passer | Ethicon |
| Surgisorb Absorbable Suture | Samyang Corporation |
Intended Use & Indications
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a 10 mm diameter scope to prevent dimming and fogging of the lens.
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.
Description
The MedChannel OptiCLEAN Lens Irrigator is a single lumen endoscopic lens irrigator, designed for attachment to 10 mm diameter endoscopes. The irrigator comes in two sizes 285 mm or 305 mm, depending on surgeon's preference. The lens irrigator provides irrigation to the lens of an endoscope to prevent dimming and fogging of the lens during endoscopic surgical procedures.
The MedChannel OptiDOCK Tissue Ligator is a single use disposable suture passer, designed for use during endoscopic procedures. The OptiDOCK Tissue Ligator is pre loaded with PGA suture (USP 2-0).
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KUS1700
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Summary of Standards Achieved
FDA Quality Systems Regulation 21 CFR § 820 ISO 10993:1 Biological evaluation of medical devices -- Part 1: Evaluation and testing ISO 10993.1 Diological evaluation of hiedred as roos - enements for validation and routine control -- radiation sterilization sterilization
AAMI 11135 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization USP 26 Absorbable Surgical Sutures USP26, 861 Sutures - Diameter
Summary
In summary, the MedChannel Endoscopic Accessories are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.
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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 arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederick Tobia Regulatory Consultant MedChannel, LLC 75 Federal Street, 9th Floor Boston, Massachusetts 02210
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Re: K051700
K031700
Trade/Device Name: OptiCLEAN Lens Irrigator & OptiDOCK Tissue Ligator Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: FEB, GAM Dated: June 10, 2005 Received: June 24, 2005
Dear Mr. Tobia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recure approval of a premarket approval application (PMA). and Cosmetter rece (110) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is elastined (tional controls. Existing major regulations affecting your device can may be subject to back acceral 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 r reaso be active a a letermination that your device complies with other requirements of the Act that I Drillana statutes and regulations administered by other Federal agencies. You must or uny x 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Frederick Tobia
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to begin manteing your and equivalence of your device to a legally premarket notheation: The PDF missing size and thus, permits 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 If you desire specific advice for your ac now on our car and the regulation entitled, and Contact the Office of Complanes at (2 + ) = = = = = = = = = = = = = = = = = = = = = = = = = " Misoranuing of Terefore to premaintenen in the Act from the Division of Small other general informational 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,
Barbara Buchen
for
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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K05/700
Indications for Use
510(k) Number (if known): _K051700
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MedChannel Endoscopic Accessories Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The OptiCLEAN Lens Irrigator is a disposable device to be used in combination with a The Option IN Lono into prevent dimming and fogging of the lens. To min diameler scope to provent aliming and 1935 - 3
The OptiDOCK Tissue Ligator is a disposable device intended to pass an absorbable suture loop during endoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Barbara Bruch MD for Melhexson | |
|---|---|
| (Division Sign-Off) |
Division of General, Restorative,
and Neurological Devices
| Page 1 of 1 | |
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510(k) Number K051700
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.