(65 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical design and clinical outcomes of a mechanical implant, with no mention of AI or ML components.
Yes
The device is intended to reduce intraocular pressure in glaucoma, a medical condition, by delivering aqueous humor through an implant, which constitutes a therapeutic intervention.
No
Explanation: The device is an implantable shunt designed to reduce intraocular pressure, categorizing it as a therapeutic device for treating glaucoma, not for diagnosing it.
No
The device description clearly details a physical implant made of silicone and polypropylene, intended for surgical implantation in the eye. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Molteno3 S-Series Function: The Molteno3 S-Series Glaucoma Implant is an implantable surgical device. It is surgically placed inside the eye to drain fluid and reduce intraocular pressure. It does not perform any diagnostic tests on samples taken from the body.
The description clearly states its purpose is to physically manage fluid within the eye to treat glaucoma, not to diagnose a condition through laboratory testing.
N/A
Intended Use / Indications for Use
The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.
Product codes
KYF
Device Description
The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.
The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.
The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.
The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Bench Testing: The materials used for the Molteno3 S-Series implant are identical to the FDA-cleared device. The device is virtually identical and produced by the identical manufacturing process. Bacterial endotoxin testing was carried out at a US testing facility and confirmed that the devices are in conformity with FDA's recommended limit of
§ 886.3920 Aqueous shunt.
(a)
Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.(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) “Aqueous Shunts—510(k) Submissions.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2015
Innovative Ophthalmic Products, Inc. (iop) % Mr. James Ravitz Partner Arent Fox. LLP 1717 K Street. NW Washington, DC 20006
Re: K152996
Trade/Device Name: Molteno3 Glaucoma Implant Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: October 12, 2015 Received: October 14, 2015
Dear Mr. Ravitz:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
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
Indications for Use
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Page I of
3
510(K) SUMMARY
I. SUBMITTER
Innovative Ophthalmic Products, Inc. (IOP, Inc.) 3184-B Airway Avenue Costa Mesa, CA 92626
Contact Person: Bryan Weinmann Phone: 714-549-1185 Fax: 714-549-0577
Date Prepared: November 13, 2015
II. DEVICE
Name of Device: Molteno3 S-Series Common or Usual Name: Glaucoma Implant Classification Name: Aqueous Shunt (21 CFR 886.3920) Regulatory Class: II Product Code: KYF
III.PREDICATE DEVICE
Molteno3 G-Series Implant (K062252). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.
The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.
The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.
The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.
AFDOCS/12673853.1
4
V. INDICATIONS FOR USE
The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.
| Molteno3 G-Series (K062252) | Molteno3 S-Series | |
|---|---|---|
| Indication for Use | The Molteno3 G-Series Glaucoma Implant | |
| is intended to reduce intraocular pressure in | ||
| neovascular glaucoma and glaucoma where | ||
| medical and conventional surgical | ||
| treatments have not been successful to | ||
| control the progression of disease. | The Molteno3 S-Series Glaucoma Implant | |
| is intended to reduce intraocular pressure | ||
| in neovascular glaucoma and glaucoma | ||
| where medical and conventional surgical | ||
| treatments have not been successful to | ||
| control the progression of disease. | ||
| Materials/Composition | Polypropylene episcleral plate attached to | |
| silicone drainage tube using silicone | ||
| adhesive. No color additives used - all | ||
| components are colorless. | Polypropylene episcleral plate attached to | |
| silicone drainage tube using silicone | ||
| adhesive. No color additives used – all | ||
| components are colorless. | ||
| Surface Area of Plate | GS = 175mm² single plate GL = 230mm² | |
| single plate | SS = 185mm² single plate SL = 245mm² | |
| single plate | ||
| Plate Thickness | 0.4mm | 0.4mm |
| Ridge Height above | ||
| Lower Surface of Plate | 1.15mm | 0.95mm |
| Maximum Plate Length | GS = 14.2mm | |
| GL = 16.0mm | SS = 15.4mm | |
| SL = 17.4mm | ||
| Maximum Plate Width | GS = 13.6mm | |
| GL = 15mm | SS = 13.6mm | |
| SL = 15mm | ||
| Tubing | Internal diameter: 0.34mm External | |
| diameter: 0.64mm | Internal diameter: 0.34mm External | |
| diameter: 0.64mm | ||
| Translimbal Tube | ||
| Length | GS = 19mm | |
| GL = 17mm | SS = 19mm | |
| SL = 17mm | ||
| Sterilization Method | Steam Autoclave ISO 17665:1 | Steam Autoclave ISO 17665:1 |
| Recommended Usage | Single Use | Single Use |
| How Supplied | Sterile | Sterile |
| Shelf Life | 5 years from sterilization | 5 years from sterilization |
| Packaging | Polypropylene Presentation Box | Polypropylene Presentation Box |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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The S-Series device differs from the predicate G-Series device only in that the S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position As a result of these changes, the overall plate length has increased very slightly.
VII. PERFORMANCE DATA
A. Bench Testing
As described in the substantial equivalence comparison chart above, the materials used for the Molteno3 S-Series implant are identical to the FDA-cleared device. Moreover, the devices is virtually identical and the devices are produced by the identical manufacturing process. Accordingly, the bench testing described in FDA's 1998 guidance document entitled "Aqueous Shunts - 510(k) Submissions" and the associated ANSI Standard Z80.27 "for Ophthalmics - Implantable Glaucoma Devices" was deemed to be unnecessary. Although sterilization procedures have also not changed, bacterial endotoxin testing was nevertheless carried out at a US testing facility and confirmed that the devices are in conformity with FDA's recommended limit of ≤0.2 EU/device.
B. Clinical Evidence Supporting Substantial Equivalence
Clinical data developed using both the G-Series implants support the conclusion that the performance of the S-Series implant is equivalent to that of the G-Series. More specifically, clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data from the Otago Glaucoma Surgery Outcome study and a similar Finnish study, along with additional unpublished data from the Otago study. Clinical performance of the aqueous shunt under investigation was compared to appropriate historical populations, and the analysis included data from 70 patients receiving the S-Series implant followed out for at least one year. Outcome data for IOP and post-operative reductions, as well as visual acuity, were evaluated, along with data on relevant adverse events. The comparison established that there is no clinically significant difference in outcome between the devices, confirming that the Molteno3 S-Series implant is as safe and effective as the predicate Molteno3 G-Series implant.
VIII. CONCLUSIONS
In summary, the Molteno3 S-Series implant and the G-Series implant are manufactured from the same materials and according to the same manufacturing process, are packaged and labeled identically, and have the same Indication for Use and the same technological characteristics. Clinical data establish that the S-Series device is as safe and effective as the predicate G-Series device. The information presented in this submission thus establishes that the Molteno3 S-Series implant is substantially equivalent to the Molteno3 G-Series implant.