(29 days)
Not Found
No
The device description focuses on a mechanical valve mechanism and material changes, with no mention of AI or ML.
Yes
The device is indicated for the management of refractory glaucomas and functions to maintain intraocular pressure within the appropriate physiological range, which are therapeutic actions.
No
The device description indicates that the Ahmed Glaucoma Valve Model FP8 is designed to manage refractory glaucomas by regulating intraocular pressure, not to diagnose the condition.
No
The device description clearly outlines physical components made of silicone and polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, 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.
- Device Description: The Ahmed Glaucoma Valve Model FP8 is an implantable device designed to manage glaucoma by regulating fluid outflow from the eye. It is a physical device implanted 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, which is a treatment, not a diagnostic test.
The description clearly indicates a surgically implanted device for therapeutic purposes, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The Ahmed Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas 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 medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.
Product codes (comma separated list FDA assigned to the subject device)
KYF
Device Description
The Ahmed® is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP8 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the surface of the endplate. The valve in the AGV-FP8 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP8 (Modified) maintains intraocular pressure within the appropriate physiological range.
In both the AGV-FP8 (Original) and AGV-FP8 (Modified), the silicone sheet is folded and pressed between two polypropylene plates. In both the predicate devices and the AGV-FP8 (Modified), the polypropylene bottom plate is separate from the silicone endplate material. The valve mechanism is inserted into a pocket in the silicone endplate to fixate the valve components to the endplate. Both the predicate devices and AGV-FP8 (Modified) have the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
The Ahmed® Glaucoma Valve Model FP8 (Modified) was tested for Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Physical Stability testing, Chemical Testing, and Aqueous Aging Testing (Hydrolytic Stability) to support the purposed change.
The results of the testing indicated that the change to the material did not pose any new risk to the device. All testing provided in the submission utilized well-established methods to evaluate the proposed change, all testing methods and acceptance criteria are the same as the proposed predicate devices.
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.
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 12, 2023
New World Medical, Inc. Mr. Victor Arellano Senior Global Regulatory Affairs Manager 19763 Edison Court Rancho Cucamonga, California 91730
Re: K231051
Trade/Device Name: Ahmed® Glaucoma Valve Model FP8 Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: April 12, 2023 Received: April 13, 2023
Dear Mr. Arellano:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Claudine H. Krawczyk -S
for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231051
Device Name Ahmed® Glaucoma Valve Model FP8
Indications for Use (Describe)
The Ahmed Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas 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 medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for New World Medical. The logo consists of a green, abstract, spherical shape on the left, followed by the words "NEW WORLD" in a simple, sans-serif font. Below "NEW WORLD" is the word "MEDICAL" in a smaller font size.
510(k) SUMMARY - K231051
This 510(k) Summary has been prepared in accordance with 21 CFR 807.92
a) Date Prepared and Submitted: 05/11/2023.
b) Address and Registration
Submitter: New World Medical, Inc.
The address and registration number of the manufacturer and sterilization site of all Ahmed® Glaucoma Valve Models are:
| Manufacturer | Sterilization Site |
|---|---|
| New World Medical, Inc. | |
| 10763 Edison Court | |
| Rancho Cucamonga, CA 91730 | |
| Phone: 909-466-4303 ext. 118 | |
| Contact Person: Victor Arellano | Sterigenics U.S., LLC |
| 344 Bonnie Circle | |
| Corona, CA 92880 | |
| FDA REGISTRATION#: 1000125279 | FDA REGISTRATION #: 2029275 |
c) Device Name
Decision Date:
| Device Trade Name: | Ahmed® Glaucoma Valve Implant Model FP8 |
|---|---|
| Common Name: | Glaucoma Drainage Device |
| Classification Name: | Aqueous Shunt (21 CFR 886.3920) |
| Product Code: | KYF |
| Device Class: | Class II – Ophthalmic Panel |
| d) Predicate Device | |
| 510(k) Number: | K171451 |
| Device Name: | Ahmed® Glaucoma Valve Model FP8 |
08/08/2017
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Image /page/4/Picture/0 description: The image shows the logo for New World Medical. The logo features a green, abstract, three-dimensional shape on the left. To the right of the shape, the words "NEW WORLD" are written in a simple, sans-serif font, with the word "MEDICAL" written below in a smaller font size.
e) Intended Use
The Ahmed Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas 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 medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.
This is the same intended use as the previously cleared Ahmed® Glaucoma Valve FP8, 510(k) Number K171451
f) Device Description and Technological Characteristics
The Ahmed® is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP8 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the surface of the endplate. The valve in the AGV-FP8 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP8 (Modified) maintains intraocular pressure within the appropriate physiological range.
In both the AGV-FP8 (Original) and AGV-FP8 (Modified), the silicone sheet is folded and pressed between two polypropylene plates. In both the predicate devices and the AGV-FP8 (Modified), the polypropylene bottom plate is separate from the silicone endplate material. The valve mechanism is inserted into a pocket in the silicone endplate to fixate the valve components to the endplate. Both the predicate devices and AGV-FP8 (Modified) have the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue
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Image /page/5/Picture/0 description: The image shows the logo for New World Medical. The logo features a green, abstract, spherical shape on the left. To the right of the shape, the words "NEW WORLD" are written in a gray, sans-serif font, with the word "MEDICAL" written below in a smaller font.
Special 510(k) Ahmed® Glaucoma Valve Model FP8 K231051
g) Proposed Change
The AGV-FP8 (modified) is a modification to the AGV-FP8 (original) in which the endplate material has been changed from one grade of silicone (NuSil MED 4840) to a slightly firmer grade of silicone (NuSil MED 4850).
h) Testing
The Ahmed® Glaucoma Valve Model FP8 (Modified) was tested for Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Physical Stability testing, Chemical Testing, and Aqueous Aging Testing (Hydrolytic Stability) to support the purposed change.
The results of the testing indicated that the change to the material did not pose any new risk to the device. All testing provided in the submission utilized well-established methods to evaluate the proposed change, all testing methods and acceptance criteria are the same as the proposed predicate devices.
Conclusion i)
In conclusion, the change to the endplate material to a slightly firmer grade of silicone does not raise new questions of safety and efficacy. Based on the non-clinical performance data, Ahmed® Glaucoma Valve Model FP8 (modified) described in this substantially equivalent to the predicate device.