(53 days)
The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.
The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.
The provided document describes the UNFOLDER Vitan™ Inserter, Model DK9000, which is an intraocular lens (IOL) inserter. It is a Class I device used to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, in combination with the SmartLOAD™ Delivery Technology. The document does not describe an AI/ML device per se but a medical device in general. Therefore, some of the requested information, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about AI/ML algorithm training, are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table detailing numerical acceptance criteria and reported device performance for specific metrics. Instead, it generally states that the device "complies with applicable standards" and "passed all acceptance criteria" during functional testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reprocessing (Reusability/Durability) | Withstood 500 clinical reprocessing cycles (CRC) without losing functional properties. Devices remained intact and successfully delivered IOLs per Directions for Use (DFU), with no degradation of functional surfaces, mating surfaces, identification marks, thread forms, or functional capability. |
| Functional Delivery | All tested IOLs under simulated surgical manipulation passed all acceptance criteria for: - Post-delivery dioptric power - Image quality - Overall diameter - Sagitta - Surface and bulk homogeneity |
| Overall Safety and Effectiveness | Demonstrated substantial equivalence to predicate devices. Functional requirements and product specifications will be met prior to commercial release. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Reprocessing Study: The study involved processing a sufficient number of UNFOLDER Vitan™ Inserters to verify that they can withstand 500 clinical reprocessing cycles. The exact number of inserters tested is not specified but it states "the inserters" implying multiple units.
- Functional Delivery Testing: "All tested IOLs" were evaluated. The exact number of IOLs tested is not specified, but the phrase implies a representative sample.
- Data Provenance: The studies were non-clinical tests conducted by Johnson & Johnson Surgical Vision, Inc. There is no information about the country of origin of the data as it's not patient-specific data, but rather device performance data. The studies are described as verification and validation testing, which are typically prospective in nature to assess product performance against design specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
This information is not applicable as the described tests are non-clinical device performance tests. Ground truth in the context of expert consensus is typically associated with clinical studies or AI/ML evaluations where human experts label or interpret data. For device performance testing, "ground truth" is typically defined by engineering specifications and objective measurements against those specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations when there's a need for consensus among multiple human readers/experts to establish a definitive "ground truth" for ambiguous cases. For device performance testing, results are typically determined by objective measurements and passing/failing predefined specification limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, often with and without AI assistance, which is not relevant for a standalone medical device like an IOL inserter that doesn't involve interpretation by human readers in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device described is a physical instrument (IOL inserter), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Engineering Specifications and Functional Requirements: For the reprocessing study, the ground truth was the device's ability to maintain its "functional properties," remain "intact," and "successfully deliver IOLs per the Directions for Use," ultimately meeting its predefined design and performance specifications.
- Established ISO Standards (ISO 11979-3: 2012): For functional delivery testing, the "ground truth" was defined by the acceptance criteria mentioned in Section 5 of ISO 11979-3: 2012, specifically for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. These standards provide objective, measurable criteria for IOL delivery performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (as explained in point 8).
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September 13, 2019
Johnson & Johnson Surgical Vision, Inc. Silvia Jiang-Hughes, Ph.D. Project Manager, Regulatory Affairs 1700 East Saint Andrew Place Santa Ana, California 92705
Re: K191949
Trade/Device Name: UNFOLDER Vitan™ Inserter, Model DK9000 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: July 19, 2019 Received: July 22, 2019
Dear Dr. Jiang-Hughes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Bennett Walker, Ph.D. Acting Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191949
Device Name UNFOLDER Vitan™ Inserter, Model DK9000
Indications for Use (Describe)
The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONL Y into the capsular bag.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 6
6. 510(K) Summary
6.1. Applicant Information
This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21 CFR 807.92.
Submitter Information: Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place Santa Ana, CA 92799-5162, USA
Contact Person: Silvia Jiang-Hughes, Ph.D. Project Manager, Regulatory Affairs 1700 East St. Andrew Place Santa Ana, CA 92705 Tel: (714) 247-8714 Fax: (714) 566-3785 Email: jjiang55@its.jnj.com
Silvie Treng Hughes.
Date of 510(k) Summary Preparation
July 18, 2019
6.2. Subject Device
| Trade / ProprietaryName: | UNFOLDER Vitan™ Inserter, DK9000 (Previouslyreferred as DK7799) |
|---|---|
| Common Name: | Intraocular Lens Guide |
| Classification Name: | Intraocular Lens Guide per 21 CFR 886.4300 |
| Product Code: | MSS |
| Regulatory Class: | Class I |
6.3. Substantial Equivalence Summary
The device to which substantial equivalence is claimed for the UNFOLDER Vitan™ Inserter, Model DK9000, is listed in Table 6-1 below:
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Table 6-1: Predicate Devices to Which Substantial Equivalence is Claimed for the UNFOLDER Vitan™ Inserter, DK9000.
| 510(k)Number | Date of FDAClearance / 510(k)Note to File | Predicate Device | 510(k) Holder |
|---|---|---|---|
| K081382 | October 23, 2008 | Duckworth & Kent Ltd.,Injector, Model DK7786 | Duckworth and KentLtd. |
6.4. Device Description
The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.
6.5. Indications for Use
The following is the Indications for Use statement for the UNFOLDER Vitan™ Inserter, DK9000:
The UNFOLDER Vitan™ Inserter, DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.
The Indications for Use statement of the subject device is similar or equivalent to the predicate device.
The IOLs for use with Model DK9000 include J&J Vision's one-piece monofocal IOLs made from either the SENSAR® soft acrylic material or the SENSAR® soft acrylic material with a proprietary violet light-filtering chromophore that reduces transmittance of violet wavelengths. They are preloaded with the SmartLOAD™ Delivery Technology and identical to the IOLs approved in the wheelcase or daisywheel package configuration. They share the same general optical and mechanical designs, with differences in the anterior surface having either spherical or aspheric optics. The differences in the lens models validated for use with the SmartLOAD™ Delivery Technology and UNFOLDER Vitan™ Inserter do not affect the safety and effectiveness of the UNFOLDER Vitan™ Inserter.
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6.6. Technological Characteristics of the Device
The UNFOLDER Vitan™ Inserter, Model DK9000, is equivalent to its predicate device, the Duckworth & Kent Ltd. (D&K) Injector, Model DK7786, in terms of its intended use, operating principle, technological characteristics, component materials, manufacturing process, biocompatibility, steam sterilization method, performance, and FDA-recognized standards used for performance testing.
The differences between the UNFOLDER Vitan™ Inserter, Model DK9000 and the predicate device Model DK7786 consist of the following aspects:
- . The subject device Model DK9000 is designed to be attached to the SmartLOAD™ Delivery Technology (P980040/S095), in which IOL is preloaded in the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering the IOLs into the eye during cataract surgery. The predicate device Model DK7786 can only be used in combination with 1VIPR30 cartridge (K143434), The loading area difference between Model DK9000 and Model DK7786 is the orientation of the snap feature on the injector bodies. Model DK7786 engages with the wings of the 1VIPR30 cartridge while Model DK9000 engages with the body of the SmartLOAD™ Delivery Technology.
- For easy identification, the subject device Model DK9000 is colored with blue . titanium through anodizing process, whereas the predicate device model DK7786 is with gold color.
- . The subject device Model DK9000 can be operated by twisting the plunger to deliver the lenses in the capsular bag, however, the predicate device Model DK7786 is operated by pushing the plunger.
These differences have been assessed in performance testing of the subject device. Despite these differences, the other user steps for operating the device, such as cleaning and sterilization are generally the same for the subject device and the predicate device.
6.7.Summary of Non-Clinical Tests
The UNFOLDER Vitan™ Inserter, Model DK9000, has undergone testing and complies with applicable standards. A reprocessing study was conducted on the UNFOLDER Vitan™ Inserter to verify that the inserters can withstand repeated clinical re-processing cycles (CRC) without losing any of its functional properties. Performance of the UNFOLDER Vitan™ Inserters in conjunction with the SmartLOAD™ Delivery Technology were evaluated with respect to inserter compatibility, functionality, and reusability. Upon completion of the five hundred (500) CRC and functional verification, the devices remained intact and successfully delivered IOLs per the Directions for Use (DFU), with no indications on the degradation of the functional surfaces, mating surfaces,
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identification marks, thread forms or functional capability. In addition, functional delivery testing was performed on the UNFOLDER Vitan™ Inserter with the SmartLOAD™ Delivery Technology in accordance with Section 5 of ISO 11979-3: 2012. All tested IOLs under simulated surgical manipulation passed all acceptance criteria for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. The overall results demonstrated substantial equivalence between the subject device and the predicate devices with respect to functional performance. All performance testing of the UNFOLDER Vitan™ Inserter demonstrate that the device is as safe and effective as the respective predicate devices.
6.8. Summary of Clinical Tests
No clinical studies were deemed necessary to determine the safety and effectiveness of the UNFOLDER Vitan™ Inserter, Model DK9000.
6.9. Conclusions
The technological characteristics that determine the functionality and performance of the subject device, the UNFOLDER Vitan™ Inserter, Model DK9000, is substantially equivalent to the D&K Injector, Model DK7786, which is included in the scope of premarket notification K081382. The UNFOLDER Vitan™ Inserter will be manufactured in compliance with FDA and ISO quality system requirements. The data from the nonclinical tests demonstrate that the safety and effectiveness profile of the subject device is equivalent to that of the legally marketed predicate devices. Verification and validation testing demonstrate that the functional requirements and product specifications will be met prior to commercial release.
§ 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.