(93 days)
Not Found
No
The summary describes a mechanical artificial corneal device and its components, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on material properties and assembly forces.
Yes
The device is used to provide a transparent optical pathway through an opacified cornea, which is a therapeutic intervention aimed at restoring vision or corneal function.
No
Explanation: The device is an artificial corneal device (prosthesis) designed to provide a transparent optical pathway, not to diagnose a condition.
No
The device description clearly states it is an "artificial corneal device" consisting of physical components (front plate, back plate, assembly tool/pin) made of PMMA and titanium. The performance studies also detail testing related to physical properties and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a transparent optical pathway through an opacified cornea in an eye. This is a direct intervention on a living patient's body.
- Device Description: The device is an artificial corneal device implanted into the eye.
- Lack of IVD Characteristics: The description does not mention any analysis of samples taken from the body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease. IVDs are used in vitro (outside the body) to perform tests on these samples.
Therefore, the Boston KPro is a medical device intended for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HOM
Device Description
The Boston KPro, Type I Lucia is an artificial corneal device that can be used in patients with severe corneal opacity.
The Boston KPro, Type I Lucia is used after standard corneal transplant has failed or when such a transplant would be unlikely to succeed. Thus, keratoprosthesis implantation is a procedure designed to help patients whose conditions are the most difficult to treat. The Boston KPro, Type I Lucia is implanted through and fixed only to the cornea and is used for corneal blindness when 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following verification and validation activities were performed to confirm that the modified device meets its functional and performance requirements:
EO sterilization validation per ANSI/AAMI/ISO 11135:2014 and AAMI TIR28:2009/(R2013) EO residuals testing per AAMI/ANSI/ISO 10993–7: 2008(R)2012 Bioburden testing per ISO 11737-1:2006/Technical Corrigendum 1 2007 and USP (2017) Endotoxin (LAL) testing per ANSI/AAMI ST72:2011/R2016, USP (2017) and USP (2017) Cytotoxicity testing per ISO 10993-5:2009 and FDA GLP regulations (21 CFR 58)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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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3
510(k) Summary
(per 21 CFR 807.92)
| Submitter: | Massachusetts Eye and Ear Infirmary, d/b/a Boston
Keratoprosthesis
243 Charles Street
Boston, MA 02114
USA |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Larisa Gelfand
Position: Director Boston KPro Business Operations
Telephone: (617) 573-4463 |
| Consultant/Contact Person: | NAMSA Clinical & Consulting Services GmbH
Industrie Center Obernburg
63784 Obernburg am Main
Germany |
| | Primary Contact: Dr. Kristy Katzenmeyer-Pleuss, PhD
Position: Senior Medical Research Manager, Regulatory
Telephone: +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 Implant
Class: II (Special Controls)
Regulation Number: 21 CFR 886.3400 |
| Product Code: | HQM |
| Predicate Device: | Boston Keratoprosthesis (Boston KPro), Type I (Click-on design)
K121203
Cleared on May 10, 2013 |
| | |
| The Boston KPro, Type I Lucia is an artificial corneal device that
can be used in patients with severe corneal opacity. | |
| The Boston KPro, Type I Lucia is used after standard corneal
transplant has failed or when such a transplant would be unlikely
to succeed. Thus, keratoprosthesis implantation is a procedure
designed to help patients whose conditions are the most difficult
to treat. The Boston KPro, Type I Lucia is implanted through
and fixed only to the cornea and is used for corneal blindness
when 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 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. | |
| 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. |
| Substantial
Equivalence: | This Special 510(k) seeks to modify the titanium back plate
manufacturing method from machining of titanium rod stock to
photoetching and forming/bending of thin titanium sheets. The
titanium raw material type and specification is unchanged from
the predicate. Several additional small changes are also being
made to the back plate, including a change in the shape of the
circular holes to ovaloids, a change in diameter, and removal of
a slit. |
| | Aside from the new photoetching and forming/bending
processes, the other manufacturing processes for the back plate,
including the sandblasting and cleaning process performed after
the photoetching and forming/bending, remain unchanged from
the predicate device. |
| | In order to accommodate the modified back plate, several small
changes are also being made to the dimensions of the front plate |
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5
| Product Characteristics | Boston KPro, Type I
(Click-on design)
(predicate; K121203) | Boston KPro, Type I Lucia
(subject device) | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | The Boston
Keratoprosthesis 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. | Same | |
| Back Plate Material | Titanium
Type: 6Al-4V
Grade: ELI
Specification:
Grade 23
Conforms to ASTM F136 | Same | |
| Black Plate Material
Physical Form and
Manufacturing | Titanium rod stock cut by
machining on a lathe | Thin titanium sheet is now photoetched
and formed/bent
• Photoetching is subcontracted to
Tecomet, Inc. (Wilmington, MA)
• Forming/bending performed at MEEI
facility | |
| Back Plate Dimensions | 8.5 mm diameter | 7.8 mm diameter
• Diameter is within range of MEEI's
other commercially available devices:
◦ 7.0 mm and 8.5 mm for
Boston KPro Snap-on design
(K915062); | |
| | | | 8.5 mm for Boston KPro,
Type I Click-on design
(K121203) |
| Back Plate Structure | 1.2 mm diameter round
holes (16 evenly spaced) Total surface area of
16 round holes is 18.1
$mm^2$ Has a slit to facilitate
assembly | Elongated "ovaloid" slots tapered from
1.01 mm down to 0.53 mm in diameter
(16 evenly spaced) Total surface area of 16 ovaloid slots
is 23 $mm^2$ There is no longer a slit in the back plate | |
| Back Plate Curvature
Angle | 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 Lead
Angle | See drawing of predicate
Boston KPro, Type I front
plate | The stem lead angle on the front plate has
been changed slightly to allow for proper
assembly and disassembly of the new
back plate;
See drawings of Boston KPro, Type I
Lucia (subject device) front plate | |
| Front Plate Optical
Properties | Aphakic version: Available in axial
lengths of 16.0 mm to
31.00 mm Pseudophakic version: Axial length
measurement not
necessary for patients
with intraocular lens in
place and assumed to
target emmetropia | Same | |
| Assembly Tool Design | Assists in assembly of
device for implantation. | Assembly tool design has dimensions to
fit new back plate and is used for the
exact same purpose as predicate | |
| Assembly Tool Material | Delrin (Acetal resin) | Same | |
| Packaging | Wipak/Film Medical
Pouch | Same | |
| Sterilization Method | Ethylene Oxide | Same | |
| SAL | 10-6 | Same | |
| Sterilization Residuals | EO:
5.5 kg force for
disassembly | Same | |
| Manufacturing
Inspection Criteria | 100% inspection for
dimensions, burrs/cracks,
sharp edge, shadow graph
visual, actual back focal
length in air | Same | |
| Verification and
Validation Testing: | The following verification and validation activities were
performed to confirm that the modified device meets its
functional and performance requirements:
EO sterilization validation per ANSI/AAMI/ISO
11135:2014 and AAMI TIR28:2009/(R2013) EO residuals testing per AAMI/ANSI/ISO 10993–7:
2008(R)2012 Bioburden testing per ISO 11737-1:2006/Technical
Corrigendum 1 2007 and USP <61> (2017) Endotoxin (LAL) testing per ANSI/AAMI
ST72:2011/R2016, USP <85> (2017) and USP <161>
(2017) Cytotoxicity testing per ISO 10993-5:2009 and FDA
GLP regulations (21 CFR 58) | | |
6
7
8
| 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. |