(38 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a surgical implant, with no mention of AI or ML technologies.
Yes
The device is indicated for the reduction of intraocular pressure in patients with glaucoma, which is a therapeutic intervention.
No
The description indicates that this device is used to treat glaucoma by reducing intraocular pressure, not to diagnose it.
No
The device description clearly states it is comprised of a surgical grade stainless steel tube and describes physical components like a rounded tip, flat angled flange, transverse reserve openings, and an external spur. This indicates a physical implant, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes tests performed on blood, urine, tissue, etc.
- Device Function: The Blunt Tip Ex-PRESS Mini Glaucoma Shunt is a surgical implant designed to physically drain fluid from the eye to reduce intraocular pressure. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is to reduce intraocular pressure in patients with glaucoma, which is a treatment, not a diagnostic test.
- Device Description: The description details a physical implant with a tube, flange, and anchor, all designed for surgical implantation and fluid drainage.
- Lack of Diagnostic Elements: There is no mention of analyzing biological specimens, performing tests, or providing diagnostic information.
This device is a surgical implant used for the treatment of glaucoma.
N/A
Intended Use / Indications for Use
The Blunt Tip Ex-PRESS Mini Glaucoma Shunts are indicated for use in reduction of intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
Product codes
KYF
Device Description
The blunt tipped Ex-PRESS shunts are comprised of a surgical grade stainless steel tube with a rounded tip at the proximal end and a flat angled flange at the distal end. Three transverse reserve openings near the proximal end of the device serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the devices serves as a reservoir and prevents intrusion into the eye. The external spur in the middle of the implant serves as an anchor and prevents extrusion from the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chamber of the 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 was conducted per the guidance document "Guidance for Industry and for FDA Reviewers/Staff Aqueous Shunts - 510(k) Submissions" - November 16", 1998.
Bench testing demonstrates that the devices are functionally equivalent.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Summary of Safety & Effectiveness
OPTOnOL
Advancing Medical Technologies
Ltd.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Optonol Ltd.
Communication Center
Neve Ilan 90850, Israel
Tel: (972) (2) 5349666
Fax: (972) (2) 5349660 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Penny Northcutt, RAC
Senior Specialist, Surgical Regulatory Affairs
CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, GA 30097 USA
Tel: (678) 415-3214
Fax: (678) 415-3990
e-mail: penny.northcutt@cibavision.novartis.com |
| TRADE NAME: | Blunt Tip Ex-PRESS Mini Glaucoma Shunt |
| COMMON NAME: | Anterior chamber drainage device |
| CLASSIFICATION
NAME: | Implant, Eye Valve |
| DEVICE
CLASSIFICATION: | Class II per 21 CFR § 886.3920 |
| PRODUCT CODE | 86 (KYF) |
| PREDICATE DEVICE: | Ex-PRESS Mini Glaucoma Shunt
Models R-30, R-50 - K012852 |
SUBSTANTIALLY EQUIVALENT TO:
The blunt tipped Optonol Ex-PRESS™ Mini Glaucoma Shunt Model R30-1S and R50-1S is substantially equivalent to the predicate Optonol Ex-PRESS Models R30 and R50 Glaucoma Shunt cleared under 510(k) K012852.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The blunt tipped Ex-PRESS Mini Glaucoma Shunts capture aqueous fluid from the anterior chamber of the eye and transport it distally into a conjunctival bleb.
. ↑
8
1
INDICATION FOR USE:
The Blunt Tip Ex-PRESS Mini Glaucoma Shunts are indicated for use in reduction of intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
TECHNICAL CHARACTERISTICS:
The blunt tipped Ex-PRESS shunts are comprised of a surgical grade stainless steel tube with a rounded tip at the proximal end and a flat angled flange at the distal end. Three transverse reserve openings near the proximal end of the device serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the devices serves as a reservoir and prevents intrusion into the eye. The external spur in the middle of the implant serves as an anchor and prevents extrusion from the eye.
PERFORMANCE DATA:
Bench testing was conducted per the guidance document "Guidance for Industry and for FDA Reviewers/Staff Aqueous Shunts - 510(k) Submissions" - November 16", 1998.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The Blunt Tip Ex-PRESS Mini Glaucoma Shunt is substantially equivalent to its predicate, the Ex-PRESS Model R30 and R50 Glaucoma Shunt cleared under 510(k) K012852. Both devices have the same indication for use, "reducing intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed" and both devices are designed to divert aqueous humor through the implant from the anterior chamber to a subconjunctival space - the bleb. The devices are manufactured from the same materials, using the same processes. The flow restriction mechanisms are identical. Bench testing demonstrates that the devices are functionally equivalent.
28
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ontonol Ltd. c/o Penny Northcutt, RAC Surgical Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097
Re: K030350 Trade/Device Name: Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous shunt Regulatory Class: II Product Code: KYF Dated: January 31, 2003 Received: February 3, 2003
Dear Ms. Northcutt:
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. Iisting 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 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.
Image /page/2/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures in the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 1 3 2003
3
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) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.
A helyi korentthal
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
Enclosure
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Page 1 of 1
510(k) Number (if known): _KO30350
・
Device Name: EX-PRESS™ Miniature Glaucoma Family of Implants
Indications for Use:
The EX-PRESS™ Miniature Glaucoma Family of Implants are intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K030350 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ----------------------------------------------- |