(192 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical components and biological interactions of a drainage implant, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of refractory glaucomas and is designed to regulate intraocular pressure, which are therapeutic functions.
No
The device is an implant designed to regulate intraocular pressure in eyes with glaucoma; it does not diagnose a condition.
No
The device description clearly states it is a physical implant comprised of silicone and polypropylene components, designed to be surgically implanted. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Ahmed™ Glaucoma Valve is an implantable surgical device designed to regulate intraocular pressure within the eye. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for the surgical management of refractory glaucomas by providing a drainage pathway for aqueous humor. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a surgical implant for treating a condition, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Ahmed Glaucoma Valve Model M4 is intended for use in patients with intractable glaucoma to reduce intraocular pressure where medical and conventional surgical treatments have failed.
The Ahmed™ Glaucoma Valve is indicated for the management of refractory qlaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile dlaucoma, and refractory glaucomas resulting from aphakia or uveitis.
Product codes (comma separated list FDA assigned to the subject device)
KYF
Device Description
The Ahmed™ Glaucoma Valve (AGV) S3 is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve membrane. The valve membrane is sandwiched between a top plate made of polyprolylene and a complementary bottom plate made of polypropylene. The bottom plate is extended to provide for aqueous distribution and drainage. The valve body conforms to the shape of the globe at its equator and protects the valve from blockage by fibrous tissue growth.
The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3. The M4 valve system is enclosed within a porous material (MEDPOR®) made of polyethylene (MEDPOR® is well established as a safe material and has been approved by the FDA for ocular use).
An animal study comparing the AGV™-S3 and AGV™-M4 was conducted at Duke University. The study lasted for over six months and was successful in demonstrating the biocompatibility of the M4. In addition, it showed that the use of porous polyethylene in the M4 resulted in decreased collagen synthesis and increased vascularization in the tissue surrounding the implant when compared to the S3. Furthermore, resistance to outflow from the M4 to the surrounding tissue was significantly reduced when compared to the S3.(Dozier, 2006)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
An animal study comparing the AGV™-S3 and AGV™-M4 was conducted at Duke University. The study lasted for over six months and was successful in demonstrating the biocompatibility of the M4. In addition, it showed that the use of porous polyethylene in the M4 resulted in decreased collagen synthesis and increased vascularization in the tissue surrounding the implant when compared to the S3. Furthermore, resistance to outflow from the M4 to the surrounding tissue was significantly reduced when compared to the S3.(Dozier, 2006)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Kob044
SEP 1 8 2006
PREMARKET NOTIFICATION [510(K)] SUMMARY
This summary information is been submitted in accordance to the requirements of The Safe Medical Devices Act of 1990
| Distributor : | New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga, CA 91730 |
|--------------------------|-----------------------------------------------------------------------------|
| Manufacturer : | New World Medical, Inc.
10763 Edison Court
Rancho Cucamonga, CA 91730 |
| Telephone/Fax : | 909/466-4304; Fax 909/466-4305 |
| Company Contact Person : | A. Mateen Ahmed, PhD/President |
| Trade Name : | Ahmed Glaucoma Valve Model M4 |
| Common Name : | Glaucoma Implant |
| Classification : | Class : II 886.3920
Panel : Ophthalmic (OP)
Product Code : KYF |
| Date Summary Prepared : | June 5th, 2006 |
Substantial Equivalence :
The Ahmed Glaucoma Valve Model M4 is substantially equivalent to the Ahmed Glaucoma Valve Model S2 and S3 currently manufactured by New World Medical, Inc.
Intended Use :
The Ahmed Glaucoma Valve Model M4 is intended for use in patients with intractable glaucoma to reduce intraocular pressure where medical and conventional surgical treatments have failed.
1
KD60644
General Description :
The Ahmed™ Glaucoma Valve (AGV) S3 is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve membrane. The valve membrane is sandwiched between a top plate made of polyprolylene and a complementary bottom plate made of polypropylene. The bottom plate is extended to provide for aqueous distribution and drainage. The valve body conforms to the shape of the globe at its equator and protects the valve from blockage by fibrous tissue growth.
The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3. The M4 valve system is enclosed within a porous material (MEDPOR®) made of polyethylene (MEDPOR® is well established as a safe material and has been approved by the FDA for ocular use).
An animal study comparing the AGV™-S3 and AGV™-M4 was conducted at Duke University. The study lasted for over six months and was successful in demonstrating the biocompatibility of the M4. In addition, it showed that the use of porous polyethylene in the M4 resulted in decreased collagen synthesis and increased vascularization in the tissue surrounding the implant when compared to the S3. Furthermore, resistance to outflow from the M4 to the surrounding tissue was significantly reduced when compared to the S3.(Dozier, 2006)
2
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2006
New World Medical, Inc. c/o A. Mateen Ahmed, Ph.D. President 10763 Edison Court Rancho Cucamonga, CA 91730
Re: K060644
Trade/Device Name: Ahmed Glaucoma Valve Model M4 Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: August 25, 2006 Received: August 28, 2006
Dear Dr. Ahmed:
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 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.
3
Page 2 - A. Mateen Ahmed, Ph.D.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman SimWD
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
4
Applicant :___New World Medical, Inc.
510(k) Number (if Known):
Device Name : Ahmed Glaucoma Valve Implant Model M4
Indications for Use:
The Ahmed™ Glaucoma Valve is indicated for the management of refractory qlaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile dlaucoma, and refractory glaucomas resulting from aphakia or uveitis.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Current of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, Nose and Throat Devises | (Per 21 CFR 801.109) (Optional Format 1-2-96) |
| 510(k) Number | K060644 |