(207 days)
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca1o(P04)s (OH)2) implants with a minimal 95 % quaranteed purity. Their porosity is 75% (pore diameter: 200-500 um). The porosity of the hydroxyapatite facilitates its colonization by fibrovascular tissue, which offers the advantages of reduced risk of infection or implant extrusion. They are available in the following diameters: 16, 17, 18, 19, 20 and 22 mm.
The provided text describes a 510(k) submission for the "HA ORBITAL IMPLANT". This document outlines the device's characteristics and its substantial equivalence to a predicate device, rather than a study designed to establish new performance criteria or conduct a comparative effectiveness study with human readers.
Therefore, many of the requested sections regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, primarily through referencing existing standards and literature for the material.
Here's an analysis of what can be extracted based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., success rates, complication rates) for the HA ORBITAL IMPLANT itself. Instead, its acceptance is based on demonstrating that its material (hydroxyapatite) meets a recognized standard and that its performance is substantially equivalent to a predicate device, supported by existing literature on hydroxyapatite orbital implants.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Conformance | HA ORBITAL IMPLANTS are made of hydroxyapatite which conforms to ASTM F1185-88 (reapproved 1993): "Standard specification for composition of ceramic hydroxylapatite for surgical implants". |
| Biocompatibility | ASTM F1185-88, an FDA recognized consensus standard, covers material characterization and biocompatibility. |
| Safety and Effectiveness | Assessed via data reviewed from the literature. "Large and numerous studies of hydroxyapatite have been performed and have demonstrated the well tolerance, the improved motility and the low incidence of complications." (Most studies with predicate device). |
| Substantial Equivalence to Predicate Device (Bio-Eye® hydroxyapatite ocular implant) | - Same intended use (fill orbital cavity post-enucleation, evisceration, or secondary implantation).- Microporous, sphere-shaped implants with interconnected pores.- Manufactured from hydroxyapatite with the same chemical formula (Ca10(PO4)6 (OH)2).- Available in several diameters and supplied sterile. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on a literature review and a comparison to a predicate device, not a new clinical trial with a specific test set.
- Data Provenance: The document states that "Large and numerous studies" of hydroxyapatite were reviewed from the "literature," and "Most of these studies were performed with the predicate device." This suggests the data is retrospective, gathered from various published clinical studies, likely from multiple countries given the global nature of medical research, but specific countries are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set with expert-established ground truth was created for this 510(k) submission. The safety and effectiveness are supported by existing medical literature and the established use of hydroxyapatite.
4. Adjudication method for the test set
Not applicable. As there was no new test set, there was no adjudication method.
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. This device is an orbital implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is based on:
- Material Standards: Conformance to ASTM F1185-88 for hydroxyapatite composition and biocompatibility.
- Established Clinical Evidence: The collective body of evidence from "large and numerous studies" in the medical literature demonstrating the "well tolerance, the improved motility and the low incidence of complications" of hydroxyapatite orbital implants, particularly the predicate device.
- Physiological/Pathological Outcomes: The literature review discusses "reduced risk of infection or implant extrusion" and comparison of complication profiles (e.g., "overlying tissue breakdown and exposure") between hydroxyapatite and other materials.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical implant. The assessment relies on existing scientific knowledge and clinical experience with similar devices (the "literature" and "predicate device").
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Summary preparation date : April 22, 2002
K 021643
1. GENERAL INFORMATION
DEC 1 3 2002
| Trade Name | HA ORBITAL IMPLANT |
|---|---|
| Common Name | Orbital Implant |
| Classification Name | Eye Sphere Implant |
| Class | II |
| Product Code | HPZ |
| CFR section | 21 CFR 886.3320 |
| Device panel | Ophthalmology |
| Submitter's nameand address | Laboratoire VILLANOVAVILLANOVA ChirurgieSTÉPHANE VILLANOVA (Geneal Manager)30 bis Cours GambettaF 34000 MONTPELLIER - FRANCEPhone +33 (0)4 67 06 50 51Fax +33 (0)4 67 58 41 22e-mail: lab.villanova@wanadoo.fr |
| Contact | Dr Isabelle DRUBAIXIdée ConsultingPhone / fax: +33 (0)3 21 05 64 23e-mail: idrubaix@nordnet.fr |
2. PREDICATE DEVICE
| Trade Name | Bio-Eye® hydroxyapatite ocular implant |
|---|---|
| Integrated Orbital Implant Inc | |
| 510(k) | K 982562 |
| Common Name | Orbital Implant |
| Classification Name | Eye Sphere Implant |
| Class | II |
| Product Code | HPZ |
| CFR section | 21 CFR 886.3320 |
| Device panel | Ophthalmology |
3. DEVICE DESCRIPTION
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca1o(P04)s (OH)2) implants with a minimal 95 % quaranteed purity.
Their porosity is 75% (pore diameter: 200-500 um). The porosity of the hydroxyapatite facilitates its colonization by fibrovascular tissue, which offers the advantages of reduced risk of infection or implant extrusion.
They are available in the following diameters: 16, 17, 18, 19, 20 and 22 mm.
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য INTENDED USE
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
5 PERFORMANCE DATA
HA ORBITAL IMPLANTS are made of hydroxyapatite which conforms to the ASTM F1185-88 (reapproved 1993): « Standard specification for composition of ceramic hydroxylapatite for surgical implants ». This FDA recognized consensus standard covers materials characterization and biocompatibility.
The safety and effectiveness of the HA ORBITAL IMPLANTS have been assessed via data reviewed from the literature. Large and numerous studies of hydroxyapatite have been performed and have demonstrated the well tolerance, the improved motility and the low incidence of complications. Most of these studies were performed with the predicate device. The long term benefits as well risks are now well determined.
Hydroxyapatite as an ocular implant appears to offer a significant improvement over all previously used materials made of silicone. PMMA or other synthetic material. Hydroxyapatite orbital implant is associated with few post operative problems consisting mainly in overlying tissue breakdown and exposure. These complications are generally the result of inadequate surqical technique and can be easily managed.
Several studies have demonstrated that synthetic and coralline orbital implants present a similar profile in terms of complications, safety and effectiveness.
6 SUBSTANTIAL EQUIVALENCE
-
Both present and predicate devices have the same intended use that is to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
-
Both present and predicate devices are microporous sphere-shaped implants with interconnected pores.
- Both present and predicate devices are manufactured A of hydroxyapatite of the same chemical formula : (Ca10(PO4)6 (OH)2). The present device is made of surgical grade synthetic hydroxyapatite whereas the predicate device is manufactured of coralline hydroxyapatite.
-
Both present and predicate devices are available in several diameters and supplied sterile. The present device is gamma sterilized whereas the predicate device is ethylene oxide sterilized.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
DEC 13 2002
Laboratoire Villanova c/o Isabelle Drubaix Regulatory Affairs Manager IDEE Consulting Residence Blue Marine 65 rue Leon Garet Le Touquet. France
Re: K021643
Trade/Device Name: HA Orbital Implant Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: HPZ Dated: September 6, 2002 Received: October 24, 2002
Dear Dr. Drubaix:
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. 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 such 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
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Page 2 -- Isabelle Drubaix
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):
Device Name : HA ORBITAL IMPLANT
Indications for Use:
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Ca10(PO4)6 (OH)2) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Durand Jones
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K021643
Prescription Use (PER 21 CFR 801.109)
or
Over-the-Counter Use
(optional Format 1-2-96)
000001
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.