(234 days)
The Medicel IOL Injector Set and Cartridge for intraocular lenses is indicated for the insertion only of models of intraocular lenses that allow use of this injector in their approved labeling.
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile. The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.
The provided document is a 510(k) summary and FDA clearance letter for a medical device: the Medicel A.G. IOL Injector Set. This submission is for a traditional medical device, not an AI/ML-enabled device. Therefore, the questions regarding acceptance criteria, study details, and performance metrics related to AI/ML are not directly applicable to this document.
However, I can extract the information relevant to the device's performance testing as described in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device was tested for biocompatibility and compatibility with recommended intraocular lenses.
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| Biocompatibility | All contact materials have been tested for biocompatibility. |
| Compatibility with IOLs | The device was tested with each of the recommended intraocular lenses. |
| Safety and Efficacy (vs. predicate) | The IOL Injector Set is equivalent in safety and efficacy to the legally marketed predicate devices. |
Regarding the other questions, they are not applicable or cannot be answered from the provided document as it concerns a traditional medical device, not an AI/ML product.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this traditional medical device. The document mentions "The device was tested with each of the recommended intraocular lenses" but does not specify a sample size for these tests or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device relying on expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The performance is based on physical testing and comparison to predicate devices, not medical ground truth.
8. The sample size for the training set
Not applicable. There is no training set for a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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NOV - 1 2007
Medicel A.G. 510(k) Submission IOL Injector Set For Intraocular lenses 510(K) Summary March 2, 2007
(1) Submitter Information
Name: Medicel AG
Address: Luchten 1262 Wolfhalden CH 9427 Switzerland
Telephone Number: 41-71-727-1057 Fax: 41-71-727-1055
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: March 6, 2007
(2) Name of Device:
Trade Name: IOL Injector Set Common Name: Intraocular lens guide. Classification Name: Folders and injectors, intraocular lens (IOL) (MSS, 886.4300)
(3) Equivalent legally-marketed devices:
K040837, Multiject injector, Medicel AG
(4) Description
The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular whose labeling specifies this injector. The injector is available as reusable or single-use. The cartridge is single-use and is provided sterile..
(5) Intended Use
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The Medicel IOL Injector Set for intraocular lenses is intended to insert foldable intraocular lenses for lenses specifying this injector set in their labeling.
(6) Technological characteristics
The device has two basic components: an injector (available either reusable or single use) and a disposable cartridge, sold sterile. The single-use injector is made of plastic and is sold sterile. The re-usable injector is made of titanium and can be autoclaved. The cartridge is made of lubricated polypropylene.
(b) Performance data
(1) Non-clinical tests
All contact materials have been tested for biocompatibility. The device was tested with each of the recommended intraocular lenses.
(2) Clinical tests
Not required
(3) Conclusions
The IOL Injector Set is equivalent in safety and efficacy to the legally marketed predicate devices.
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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 & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEC - 4 2007
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicel AG c/o George Myers, Sc.D Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
K070669 Re:
Trade/Device Name: Medicel AG IOL Injector Set Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: KYB Dated: October 12, 2007 Received: October 15, 2007
Dear Dr. Myers:
This letter corrects our substantially equivalent letter of November 1, 2007.
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 (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 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 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egleston, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Dr. George Myers
Indications for Use
510(k) Number (if known): K070669
Device Name: Medicel AG IOL Injector Set
Indications For Use: The Medicel IOL Injector Set and Cartridge for intraocular lenses is
indicated for the insertion only of models of intraocular lenses that allow use of this
injector in their approved labeling.
Prescription Use X (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)
(Division Sign-Off) Division of Onhthalmic Ear, Nose and Throat Devises
KO70669 510(k) Number .
Page 1 of 1
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.