(120 days)
ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.
The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.
This 510(k) pertains to a manual ophthalmic surgical instrument (ClearCut™ S Incisional Instruments) that is exempt from direct performance comparison studies to establish substantial equivalence because it falls under a general control regulation (21 CFR 886.4350). Instead, the submission focuses on demonstrating compliance with safety and materials standards. Therefore, the requested information elements related to AI/algorithm performance and clinical studies are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not presented in a traditional tabular format with specific performance metrics for evaluation against a new AI algorithm. Instead, the submission focuses on meeting established standards and guidance documents related to medical devices with sharps injury prevention features and biocompatibility.
| Acceptance Criteria Category | Reference/Standard | Reported Device Performance |
|---|---|---|
| Sharps Injury Prevention | August 9, 2005, Guidance for Industry -- "Medical Devices with Sharps Injury Prevention Features." | "The ClearCut™ S Incisional Instruments have been tested in conformance with the requirements set forth in the August 9, 2005, Guidance for Industry -- 'Medical Devices with Sharps Injury Prevention Features.'" |
| Biocompatibility | ANSI/AAMI/ISO 10993 | "biocompatibility evaluations of materials coming in contact with the patient have been performed according to ANSI/AAMI/ISO 10993." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not involve a clinical test set for AI algorithm performance. The testing mentioned refers to mechanical and material compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI-driven device requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to established engineering and medical device standards for sharps injury prevention and biocompatibility. The device's compliance with these standards serves as the "ground truth" for its safety and effectiveness for its intended use.
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
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510(k): K110166
5. 510(K) SUMMARY
MAY 2 0 2011
510(k) Summary
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Tonya Morgan Sr. Regulatory Analyst, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-8723 Fax: (817) 302-4574
Date Summary Prepared: January 6, 2011
Device Subject to this 510(k):
| Trade Name: | ClearCut™ S Incisional Instruments |
|---|---|
| Common Name: | Ophthalmic Knife |
| Classification Name: | Manual ophthalmic surgical instrument |
1. Predicate Devices:
The legally marketed device(s) to which we are claiming substantial equivalence are:
| 510(k) Number | Device |
|---|---|
| Exempt per 21CFR 886.4350 | BD Beaver Safety Knife |
| Exempt per 21CFR 886.4350 | KAI Safety Knife |
| Exempt per 21CFR 886.4350 | Diamatrix ProTekt Safety Knife |
2. Device Description:
The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is
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delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.
3. Indications for Use:
ClearCut™ S Incisional Instruments are sterile, single use disposable devices intended for using during ophthalmic surgical procedures.
4. Brief Summary of Nonclinical Test and Results:
The ClearCut™ S Incisional Instruments have been tested in conformance with the requirements set forth in the August 9, 2005, Guidance for Industry -- "Medical Devices with Sharps Injury Prevention Features." In addition, biocompatibility evaluations of materials coming in contact with the patient have been performed according to ANSI/AAMI/ISO 10993. Details of this testing can be found in Section 13.
5. Comparison of Technological Characteristics to Predicate Devices:
A comparison table of the ClearCut™ S Incisional Instruments and predicate devices is on the following page.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alcon Laboratories, Inc. c/o Ms. Tonya Morgan Senior Regulatory Affairs Analyst 6201 South Freeway Fort Worth, Texas 76134
MAY 2 0 2011
Re: K110166
Trade/Device Name: ClearCut S Incisional Instruments Regulation Number: 21 CFR 886.4350 Regulation Name: Manual ophthalmic surgical instrument Regulatory Class: I Product Code: HNN Dated: April 12, 2011 Received: April 13, 2011
Dear Ms. Morgan:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promance is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate referenced above and have determined the arrest breaked devices marketed in interstate for use stated in the encrosule) to regally manced people Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prof to May 20, 1970, the chartisens and the provisions of the Federal Food. Drug, devices that have been reciassince in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, merelore, market me device, seejor to me a general controls provisions of the free mortion and prohibitions against misted to contract liability devices, good manufacturing practice, laboring, and joint the truthful and not misledge adulteration. Please note: CDNT docs not overaliate in the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and be If your device is classified (See above) mio times affecting your device can be
may be subject to additional controls. Existing major regulations affective EDA may may be subject to additional Controls: "Existing major regard of 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition found in the Code of I cacial resguines in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualics of a substition with other requirements of the Act
that FDA has made a determination that your device complies with of connection of th that FDA has made a determination that your are rederal agencies. You must or any Federal statules and regulations administered by only and to: registration and listing (21
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debrah Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Page _ of _1
£110166 510(k) Number (if known):
ClearCut™ S Incisional Instruments (with Sharps Injury Device Name: Protection)
Indications for Use:
ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical 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)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110166 14
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(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 § 886.9.