(93 days)
The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
The Boston KPro, Type I Lucia is an artificial corneal device that can be used in patients with severe corneal opacity. The device consists of two components: a front plate constructed of clear polymethyl methacrylate (PMMA) plastic, and a back plate constructed of titanium that locks the device in place around a corneal donor graft. The Boston KPro, Type I Lucia is supplied with an assembly tool/pin to assist in device assembly.
The provided document describes a 510(k) submission for the Boston Keratoprosthesis, Type I Lucia (Boston KPro), which is an artificial corneal device. This is primarily a submission seeking to modify the manufacturing method of the back plate and make related minor changes to the front plate and assembly tool. The document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish new clinical performance acceptance criteria.
Therefore, the information regarding specific acceptance criteria for clinical efficacy studies, sample sizes, expert involvement, and ground truth for clinical performance is not directly provided in the context of a new clinical study with new acceptance criteria. Instead, the focus is on non-clinical testing to confirm that the modified device maintains the performance of the predicate device.
However, I can extract the relevant non-clinical acceptance criteria and the testing performed to demonstrate that the modified device meets these.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria | Reported Device Performance (Modified Device) |
|---|---|---|
| Assembly Force Specifications | < 5 kg force for assembly | Testing of the Boston KPro, Type I Lucia has demonstrated that the back plate manufacturing change... as well as other minor changes... do not modify product performance. The product has been found to fulfill prospectively defined performance criteria. (Implicitly met, no specific value stated for the Lucia model in the table, but the criteria is updated from the predicate's < 3 kg) |
| Disassembly Force Specifications | > 5.5 kg force for disassembly | Testing of the Boston KPro, Type I Lucia has demonstrated that the back plate manufacturing change... as well as other minor changes... do not modify product performance. The product has been found to fulfill prospectively defined performance criteria. (Implicitly met, "Same" as predicate means the criterion is met) |
| EO Sterilization Validation | Per ANSI/AAMI/ISO 11135:2014 and AAMI TIR28:2009/(R2013) | Performed. Confirmed modified device meets functional and performance requirements. |
| EO Residuals Testing | Per AAMI/ANSI/ISO 10993–7:2008(R)2012; EO: < 0.5 µg EO/device/day; < 1.25 µg EO/device total; ECH: < 2 µg ECH/device/day; < 5 µg ECH/device total | Performed. Confirmed modified device meets functional and performance requirements. (No specific values reported in the 'Performance' column, but implied compliance) |
| Bioburden Testing | Per ISO 11737-1:2006/Technical Corrigendum 1 2007 and USP <61> (2017); Initial Alert Limit: ≥ 28.0 CFUs/device; Initial Action Limit: ≥ 119 CFUs/device (for Aerobic, Aerobic spores, Anaerobic, Fungal) | Performed. Confirmed modified device meets functional and performance requirements. |
| Endotoxin (LAL) Testing | Per ANSI/AAMI ST72:2011/R2016, USP <85> (2017) and USP <161> (2017); ≤0.2 EU/device | Performed. Confirmed modified device meets functional and performance requirements. |
| Cytotoxicity Testing | Per ISO 10993-5:2009 and FDA GLP regulations (21 CFR 58) | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (Magnetic Field Interactions) | Translational attraction/deflection angle per ASTM F2052-15; Torque per ASTM F2213-06 (R2011) | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (MRI-related heating) | Per ASTM F2182-11a | Performed. Confirmed modified device meets functional and performance requirements. |
| MR Safety Testing (Image Artifacts) | Per ASTM F2119-07 (R2013) | Performed. Confirmed modified device meets functional and performance requirements. |
| Manufacturing Inspection Criteria | 100% inspection for dimensions, burrs/cracks, sharp edge, shadow graph visual, actual back focal length in air | Performing. (Implied to be met, "Same" as predicate means the criterion is applied) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for establishing performance metrics. The testing performed is non-clinical, verification and validation testing of the device's physical and material properties, and manufacturing process. Therefore, sample sizes would be per the requirements of the specific engineering and material tests (e.g., number of devices tested for assembly force, number of samples for chemical analysis, etc.), which are not detailed here.
- Data Provenance: Not applicable in the context of clinical patient data, as no clinical studies were performed. The non-clinical testing data would originate from the manufacturing and testing facilities of MEEI and its subcontractors (e.g., Tecomet, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth in the clinical diagnosis sense was established, as no clinical studies were conducted for this 510(k) submission. Non-clinical tests rely on established scientific methods and standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable, as no human-based clinical performance assessment or diagnostic study was performed that would require adjudication.
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
- No MRMC study was done, as this is a physical medical device (corneal implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing is based on predefined engineering specifications, material standards (e.g., ASTM, ISO), and regulatory limits. For example, the ground truth for sterilization efficacy is conformance to ISO 11135, and for material biocompatibility, it's conformance to ISO 10993.
8. The sample size for the training set
- Not applicable. No training set in the machine learning sense was used. This is a physical device modification submission.
9. How the ground truth for the training set was established
- Not applicable.
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January 30, 2019
Massachusetts Eye and Ear Infirmary d/b/a Boston % Ms. Kristy Katzenmeyer-Pleuss Senior Medical Research Manager, Regulatory NAMSA Clinical & Consulting Services, GmbH Industrie Center Obernburg 63784 Obernburg am Main Germany
Re: K182986
Trade/Device Name: Boston Keratoprosthesis, Type I Lucia Regulation Number: 21 CFR 886.3400 Regulation Name: Keratoprosthesis Regulatory Class: Class II Product Code: HOM Dated: December 26, 2018 Received: December 31, 2018
Dear Ms. Kristy Katzenmeyer-Pleuss:
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.
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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); medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Jennifer N. Brown -S
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Expiration Date: 06/30/2020 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known)
Device Name
Boston Keratoprosthesis, Type I Lucia (Boston KPro)
Indications for Use (Describe)
The Boston KPro is indicated to provide a transparent optical pathway through an opacified cornea in an eye that is not a reasonable candidate for any form of corneal transplant, including penetrating keratoplasty.
| 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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510(k) Summary
(per 21 CFR 807.92)
| Submitter: | Massachusetts Eye and Ear Infirmary, d/b/a BostonKeratoprosthesis243 Charles StreetBoston, MA 02114USA |
|---|---|
| Contact Person: Larisa GelfandPosition: Director Boston KPro Business OperationsTelephone: (617) 573-4463 | |
| Consultant/Contact Person: | NAMSA Clinical & Consulting Services GmbHIndustrie Center Obernburg63784 Obernburg am MainGermany |
| Primary Contact: Dr. Kristy Katzenmeyer-Pleuss, PhDPosition: Senior Medical Research Manager, RegulatoryTelephone: +49 151 7411 2739 | |
| Date Prepared: | October 19, 2018 |
| Trade Name: | Boston Keratoprosthesis (Boston KPro), Type I Lucia |
| Common/Usual Name: | Keratoprosthesis |
| Classification: | Classification Name: Keratoprosthesis, Permanent ImplantClass: II (Special Controls)Regulation Number: 21 CFR 886.3400 |
| Product Code: | HQM |
| Predicate Device: | Boston Keratoprosthesis (Boston KPro), Type I (Click-on design)K121203Cleared on May 10, 2013 |
| The Boston KPro, Type I Lucia is an artificial corneal device thatcan be used in patients with severe corneal opacity. | |
| The Boston KPro, Type I Lucia is used after standard cornealtransplant has failed or when such a transplant would be unlikelyto succeed. Thus, keratoprosthesis implantation is a proceduredesigned to help patients whose conditions are the most difficultto treat. The Boston KPro, Type I Lucia is implanted throughand fixed only to the cornea and is used for corneal blindnesswhen the eyelids, blink mechanism, and tear film are intact. | |
| The device consists of two components:a front plate constructed of clear polymethyl methacrylate(PMMA) plastic, and a back plate constructed of titanium that locks the devicein place around a corneal donor graft. | |
| The Boston KPro, Type I Lucia is supplied with an assemblytool/pin to assist in device assembly. | |
| Intended Use: | The Boston KPro is indicated to provide a transparent opticalpathway through an opacified cornea in an eye that is not areasonable candidate for any form of corneal transplant,including penetrating keratoplasty. |
| SubstantialEquivalence: | This Special 510(k) seeks to modify the titanium back platemanufacturing method from machining of titanium rod stock tophotoetching and forming/bending of thin titanium sheets. Thetitanium raw material type and specification is unchanged fromthe predicate. Several additional small changes are also beingmade to the back plate, including a change in the shape of thecircular holes to ovaloids, a change in diameter, and removal ofa slit. |
| Aside from the new photoetching and forming/bendingprocesses, the other manufacturing processes for the back plate,including the sandblasting and cleaning process performed afterthe photoetching and forming/bending, remain unchanged fromthe predicate device. | |
| In order to accommodate the modified back plate, several smallchanges are also being made to the dimensions of the front plate |
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| Product Characteristics | Boston KPro, Type I(Click-on design)(predicate; K121203) | Boston KPro, Type I Lucia(subject device) | |
|---|---|---|---|
| Intended Use | The BostonKeratoprosthesis isindicated to provide atransparent opticalpathway through anopacified cornea in an eyethat is not a reasonablecandidate for any form ofcorneal transplant,including penetratingkeratoplasty. | Same | |
| Back Plate Material | TitaniumType: 6Al-4VGrade: ELISpecification:Grade 23Conforms to ASTM F136 | Same | |
| Black Plate MaterialPhysical Form andManufacturing | Titanium rod stock cut bymachining on a lathe | Thin titanium sheet is now photoetchedand formed/bent• Photoetching is subcontracted toTecomet, Inc. (Wilmington, MA)• Forming/bending performed at MEEIfacility | |
| Back Plate Dimensions | 8.5 mm diameter | 7.8 mm diameter• Diameter is within range of MEEI'sother commercially available devices:◦ 7.0 mm and 8.5 mm forBoston KPro Snap-on design(K915062); | |
| 8.5 mm for Boston KPro,Type I Click-on design(K121203) | |||
| Back Plate Structure | 1.2 mm diameter roundholes (16 evenly spaced) Total surface area of16 round holes is 18.1$mm^2$ Has a slit to facilitateassembly | Elongated "ovaloid" slots tapered from1.01 mm down to 0.53 mm in diameter(16 evenly spaced) Total surface area of 16 ovaloid slotsis 23 $mm^2$ There is no longer a slit in the back plate | |
| Back Plate CurvatureAngle | 20.00° | Same | |
| Back Plate Thickness | 0.30 mm | Same | |
| Front Plate Material | Polymethylmethacrylate(PMMA) | Same | |
| Front Plate Dimensions: | Diameter 5.0 mm Stem Length 1.7 mm | Same | |
| Front Plate Stem LeadAngle | See drawing of predicateBoston KPro, Type I frontplate | The stem lead angle on the front plate hasbeen changed slightly to allow for properassembly and disassembly of the newback plate;See drawings of Boston KPro, Type ILucia (subject device) front plate | |
| Front Plate OpticalProperties | Aphakic version: Available in axiallengths of 16.0 mm to31.00 mm Pseudophakic version: Axial lengthmeasurement notnecessary for patientswith intraocular lens inplace and assumed totarget emmetropia | Same | |
| Assembly Tool Design | Assists in assembly ofdevice for implantation. | Assembly tool design has dimensions tofit new back plate and is used for theexact same purpose as predicate | |
| Assembly Tool Material | Delrin (Acetal resin) | Same | |
| Packaging | Wipak/Film MedicalPouch | Same | |
| Sterilization Method | Ethylene Oxide | Same | |
| SAL | 10-6 | Same | |
| Sterilization Residuals | EO:< 0.5 µg EO/device/day; | Same | |
| < 1.25 µg EO/device totalECH:< 2 µg ECH/device/day;< 5 µg ECH/device total | |||
| Endotoxin Limits | ≤0.2 EU/device | Same | |
| Bioburden Limits | Initial Alert Limit:Bioburden$\geq$ 28.0CFUs/device | Same | |
| Initial Action Limit:Bioburden$\geq$ 119CFUs/device | |||
| Note: Bioburden limitsapply to each of thefollowing:AerobicAerobic sporesAnaerobicFungal | |||
| MR Labeling | MR-Conditional | Same | |
| Assembly ForceSpecifications | < 3 kg force for assembly | < 5 kg force for assembly | |
| Disassembly ForceSpecifications | > 5.5 kg force fordisassembly | Same | |
| ManufacturingInspection Criteria | 100% inspection fordimensions, burrs/cracks,sharp edge, shadow graphvisual, actual back focallength in air | Same | |
| Verification andValidation Testing: | The following verification and validation activities wereperformed to confirm that the modified device meets itsfunctional and performance requirements:EO sterilization validation per ANSI/AAMI/ISO11135:2014 and AAMI TIR28:2009/(R2013) EO residuals testing per AAMI/ANSI/ISO 10993–7:2008(R)2012 Bioburden testing per ISO 11737-1:2006/TechnicalCorrigendum 1 2007 and USP <61> (2017) Endotoxin (LAL) testing per ANSI/AAMIST72:2011/R2016, USP <85> (2017) and USP <161>(2017) Cytotoxicity testing per ISO 10993-5:2009 and FDAGLP regulations (21 CFR 58) |
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| MR Safety Testing Magnetic field interactions: translational attraction/deflection angle per ASTM F2052-15 and torque per ASTM F2213-06 (R2011) MRI-related heating per ASTM F2182-11a Image Artifacts per ASTM F2119-07 (R2013) Device assembly force testing Device disassembly force testing Testing of the Boston KPro, Type I Lucia has demonstrated that the back plate manufacturing change from machining to photoetching and forming/bending as well as other minor changes to the back plate, front plate, and assembly tool do not modify product performance. The product has been found to fulfill prospectively defined performance criteria and that the modified device meets user needs.No preclinical animal or clinical testing was performed to establish substantial equivalence to the predicate. |
|---|
| Conclusion: MEEI considers the modified device (Boston KPro, Type I Lucia) to be substantially equivalent to the predicate Boston KPro, Type I (Click-on device) cleared under K121203. This conclusion is based upon the devices' similarities in technological characteristics, performance specifications, raw materials, and indications for use. As mentioned above, there are only minor differences between the subject and predicate devices. Non-clinical testing performed confirms that these minor differences do not affect the device's safety or effectiveness as the modified device meets the same functional and safety requirements as the predicate. Therefore, the two devices can be considered substantially equivalent. |
| In conclusion, the subject device (Boston KPro, Type I Lucia) described in this application can be considered substantially equivalent to the predicate device [Boston KPro, Type I (Click-on) model] cleared under K121203. |
§ 886.3400 Keratoprosthesis.
(a)
Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”