Boston Keratoprosthesis, Type I Lucia

K182986 · Massachusetts Eye and Ear Infirmary D/B/A Boston · HQM · Jan 30, 2019 · Ophthalmic

Device Facts

• Record ID: K182986
• Device Name: Boston Keratoprosthesis, Type I Lucia
• Applicant: Massachusetts Eye and Ear Infirmary D/B/A Boston
• Product Code: HQM · Ophthalmic
• Decision Date: Jan 30, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Artificial corneal device; provides transparent optical pathway through opacified cornea. Consists of clear PMMA front plate and titanium back plate; locks around corneal donor graft. Implanted through and fixed to cornea. Used in patients where standard corneal transplant failed or is unlikely to succeed. Requires intact eyelids, blink mechanism, and tear film. Physician-implanted in clinical setting. Back plate manufacturing uses photoetching and forming/bending of titanium sheets. Assembly tool assists in device placement. Device provides optical correction for corneal blindness.

Clinical Evidence

Bench testing only. No clinical or animal data provided. Verification included EO sterilization validation (ANSI/AAMI/ISO 11135:2014), EO residuals (ISO 10993-7), bioburden (ISO 11737-1), endotoxin (ANSI/AAMI ST72:2011), cytotoxicity (ISO 10993-5), and MR safety (ASTM F2052-15, F2213-06, F2182-11a, F2119-07).

Technological Characteristics

Artificial cornea; PMMA front plate; 6Al-4V ELI titanium (ASTM F136) back plate. Back plate manufactured via photoetching and forming. Dimensions: 7.8 mm back plate diameter. Sterilization: Ethylene Oxide (SAL 10^-6). MR-Conditional. Assembly tool: Delrin (Acetal resin).

Indications for Use

Indicated for patients with severe corneal opacity who are not candidates for corneal transplant, including penetrating keratoplasty. Intended for use in eyes with intact eyelids, blink mechanism, and tear film.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Boston Keratoprosthesis (Boston KPro), Type I (Click-on design) (K121203)

Reference Devices

• Boston KPro Snap-on design (K915062)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary

## (per 21 CFR 807.92)

| Submitter: | Massachusetts Eye and Ear Infirmary, d/b/a Boston<br>Keratoprosthesis<br>243 Charles Street<br>Boston, MA 02114<br>USA |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Larisa Gelfand<br>Position: Director Boston KPro Business Operations<br>Telephone: [phone] |
| Consultant/Contact Person: | NAMSA Clinical & Consulting Services GmbH<br>Industrie Center Obernburg<br>63784 Obernburg am Main<br>Germany |
| | Primary Contact: Dr. Kristy Katzenmeyer-Pleuss, PhD<br>Position: Senior Medical Research Manager, Regulatory<br>Telephone: [phone] |
| Date Prepared: | October 19, 2018 |
| Trade Name: | Boston Keratoprosthesis (Boston KPro), Type I Lucia |
| Common/Usual Name: | Keratoprosthesis |
| Classification: | Classification Name: Keratoprosthesis, Permanent Implant<br>Class: II (Special Controls)<br>Regulation Number: 21 CFR 886.3400 |
| Product Code: | HQM |
| Predicate Device: | Boston Keratoprosthesis (Boston KPro), Type I (Click-on design)<br>K121203<br>Cleared on May 10, 2013 |
| | |
| The Boston KPro, Type I Lucia is an artificial corneal device that<br>can be used in patients with severe corneal opacity. | |
| The Boston KPro, Type I Lucia is used after standard corneal<br>transplant has failed or when such a transplant would be unlikely<br>to succeed. Thus, keratoprosthesis implantation is a procedure<br>designed to help patients whose conditions are the most difficult<br>to treat. The Boston KPro, Type I Lucia is implanted through<br>and fixed only to the cornea and is used for corneal blindness<br>when the eyelids, blink mechanism, and tear film are intact. | |
| The device consists of two components:<br>a front plate constructed of clear polymethyl methacrylate<br>(PMMA) plastic, and a back plate constructed of titanium that locks the device<br>in place around a corneal donor graft. | |
| The Boston KPro, Type I Lucia is supplied with an assembly<br>tool/pin to assist in device assembly. | |
| Intended Use: | The Boston KPro is indicated to provide a transparent optical<br>pathway through an opacified cornea in an eye that is not a<br>reasonable candidate for any form of corneal transplant,<br>including penetrating keratoplasty. |
| Substantial<br>Equivalence: | This Special 510(k) seeks to modify the titanium back plate<br>manufacturing method from machining of titanium rod stock to<br>photoetching and forming/bending of thin titanium sheets. The<br>titanium raw material type and specification is unchanged from<br>the predicate. Several additional small changes are also being<br>made to the back plate, including a change in the shape of the<br>circular holes to ovaloids, a change in diameter, and removal of<br>a slit. |
| | Aside from the new photoetching and forming/bending<br>processes, the other manufacturing processes for the back plate,<br>including the sandblasting and cleaning process performed after<br>the photoetching and forming/bending, remain unchanged from<br>the predicate device. |
| | In order to accommodate the modified back plate, several small<br>changes are also being made to the dimensions of the front plate |

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| Product Characteristics | Boston KPro, Type I<br>(Click-on design)<br>(predicate; K121203) | Boston KPro, Type I Lucia<br>(subject device) | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | The Boston<br>Keratoprosthesis is<br>indicated to provide a<br>transparent optical<br>pathway through an<br>opacified cornea in an eye<br>that is not a reasonable<br>candidate for any form of<br>corneal transplant,<br>including penetrating<br>keratoplasty. | Same | |
| Back Plate Material | Titanium<br>Type: 6Al-4V<br>Grade: ELI<br>Specification:<br>Grade 23<br>Conforms to ASTM F136 | Same | |
| Black Plate Material<br>Physical Form and<br>Manufacturing | Titanium rod stock cut by<br>machining on a lathe | Thin titanium sheet is now photoetched<br>and formed/bent<br>• Photoetching is subcontracted to<br>Tecomet, Inc. (Wilmington, MA)<br>• Forming/bending performed at MEEI<br>facility | |
| Back Plate Dimensions | 8.5 mm diameter | 7.8 mm diameter<br>• Diameter is within range of MEEI's<br>other commercially available devices:<br>◦ 7.0 mm and 8.5 mm for<br>Boston KPro Snap-on design<br>(K915062); | |
| | | | 8.5 mm for Boston KPro,<br>Type I Click-on design<br>(K121203) |
| Back Plate Structure | 1.2 mm diameter round<br>holes (16 evenly spaced) Total surface area of<br>16 round holes is 18.1<br>$mm^2$ Has a slit to facilitate<br>assembly | Elongated "ovaloid" slots tapered from<br>1.01 mm down to 0.53 mm in diameter<br>(16 evenly spaced) Total surface area of 16 ovaloid slots<br>is 23 $mm^2$ There is no longer a slit in the back plate | |
| Back Plate Curvature<br>Angle | 20.00° | Same | |
| Back Plate Thickness | 0.30 mm | Same | |
| Front Plate Material | Polymethylmethacrylate<br>(PMMA) | Same | |
| Front Plate Dimensions: | Diameter 5.0 mm Stem Length 1.7 mm | Same | |
| Front Plate Stem Lead<br>Angle | See drawing of predicate<br>Boston KPro, Type I front<br>plate | The stem lead angle on the front plate has<br>been changed slightly to allow for proper<br>assembly and disassembly of the new<br>back plate;<br>See drawings of Boston KPro, Type I<br>Lucia (subject device) front plate | |
| Front Plate Optical<br>Properties | Aphakic version: Available in axial<br>lengths of 16.0 mm to<br>31.00 mm Pseudophakic version: Axial length<br>measurement not<br>necessary for patients<br>with intraocular lens in<br>place and assumed to<br>target emmetropia | Same | |
| Assembly Tool Design | Assists in assembly of<br>device for implantation. | Assembly tool design has dimensions to<br>fit new back plate and is used for the<br>exact same purpose as predicate | |
| Assembly Tool Material | Delrin (Acetal resin) | Same | |
| Packaging | Wipak/Film Medical<br>Pouch | Same | |
| Sterilization Method | Ethylene Oxide | Same | |
| SAL | 10-6 | Same | |
| Sterilization Residuals | EO:<br>< 0.5 µg EO/device/day; | Same | |
| < 1.25 µg EO/device total<br>ECH:<br>< 2 µg ECH/device/day;<br>< 5 µg ECH/device total | | | |
| Endotoxin Limits | ≤0.2 EU/device | Same | |
| Bioburden Limits | Initial Alert Limit:<br>Bioburden<br>$\geq$ 28.0<br>CFUs/device | Same | |
| | Initial Action Limit:<br>Bioburden<br>$\geq$ 119<br>CFUs/device | | |
| | Note: Bioburden limits<br>apply to each of the<br>following:<br>Aerobic<br>Aerobic spores<br>Anaerobic<br>Fungal | | |
| MR Labeling | MR-Conditional | Same | |
| Assembly Force<br>Specifications | < 3 kg force for assembly | < 5 kg force for assembly | |
| Disassembly Force<br>Specifications | > 5.5 kg force for<br>disassembly | Same | |
| Manufacturing<br>Inspection Criteria | 100% inspection for<br>dimensions, burrs/cracks,<br>sharp edge, shadow graph<br>visual, actual back focal<br>length in air | Same | |
| Verification and<br>Validation Testing: | The following verification and validation activities were<br>performed to confirm that the modified device meets its<br>functional and performance requirements:<br>EO sterilization validation per ANSI/AAMI/ISO<br>11135:2014 and AAMI TIR28:2009/(R2013) EO residuals testing per AAMI/ANSI/ISO 10993–7:<br>2008(R)2012 Bioburden testing per ISO 11737-1:2006/Technical<br>Corrigendum 1 2007 and USP &lt61> (2017) Endotoxin (LAL) testing per ANSI/AAMI<br>ST72:2011/R2016, USP &lt85> (2017) and USP &lt161><br>(2017) Cytotoxicity testing per ISO 10993-5:2009 and FDA<br>GLP 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.<br>No preclinical animal or clinical testing was performed to establish substantial equivalence to the predicate. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Conclusion:</b> 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. |