HA ORBITAL IMPLANT

K021643 · Laboratoire Villanova · HPZ · Dec 13, 2002 · Ophthalmic

Device Facts

• Record ID: K021643
• Device Name: HA ORBITAL IMPLANT
• Applicant: Laboratoire Villanova
• Product Code: HPZ · Ophthalmic
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

HA Orbital Implant is a synthetic hydroxyapatite sphere used to fill the orbital cavity after enucleation, evisceration, or secondary implantation. The device features a porous structure (75% porosity, 200-500 um pore diameter) designed to facilitate fibrovascular tissue ingrowth, which reduces risks of infection and implant extrusion. It is available in diameters ranging from 16 to 22 mm. The implant is surgically placed by an ophthalmologist within the orbital cavity. By integrating with host tissue, the implant provides a stable base for ocular prosthetics, improving motility and cosmetic outcomes compared to non-porous materials like silicone or PMMA. The device is supplied sterile.

Clinical Evidence

No clinical data generated for this specific device. Safety and effectiveness were established via literature review of hydroxyapatite ocular implants, demonstrating well-tolerated outcomes, improved motility, and low complication rates comparable to the predicate device.

Technological Characteristics

Synthetic hydroxyapatite (Ca10(PO4)6(OH)2) conforming to ASTM F1185-88. Microporous sphere geometry (75% porosity, 200-500 um pore diameter). Available in 16-22 mm diameters. Gamma sterilized.

Indications for Use

Indicated for patients requiring orbital cavity volume replacement following enucleation, evisceration, or secondary implantation procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bio-Eye® hydroxyapatite ocular implant (K982562)

Submission Summary (Full Text)

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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 name<br>and address | Laboratoire VILLANOVA<br>VILLANOVA Chirurgie<br>STÉPHANE VILLANOVA (Geneal Manager)<br>30 bis Cours Gambetta<br>F 34000 MONTPELLIER - FRANCE<br>Phone [phone]<br>Fax [phone]<br>e-mail: [e-mail] |
| Contact | Dr Isabelle DRUBAIX<br>Idée Consulting<br>Phone / fax: [phone]<br>e-mail: [e-mail] |

### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

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