(37 days)
Not Found
No
The device description focuses on a mechanical valve mechanism and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device is indicated for the management of refractory glaucomas and designed to regulate intraocular pressure, which are therapeutic interventions addressing a health condition.
No
The device is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma, not to diagnose a condition.
No
The device description clearly details a physical implantable device made of silicone and polypropylene, designed to regulate intraocular pressure. It is not software.
Based on the provided information, 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 Model FP7 is an implantable surgical device designed to regulate intraocular pressure within the eye. It is physically placed inside 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 performed on a sample outside the body.
The description clearly indicates a device that is surgically implanted to treat a condition, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ahmed® Glaucoma Valve Model FP7 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® Glaucoma Valve Model FP7 (AGV-FP7) (Modified) 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 mechanism. This valve mechanism is the same in the predicate AGV-FP7 (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 eye over the surface of the endplate. The valve in the AGV-FP7 (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-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.
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 FP7 (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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May 12, 2023
New World Medical, Inc. Mr. Victor Arellano Senior Global Regulatory Affairs Manager 19763 Edison Court Rancho Cucamonga, California 91730
Re: K230975
Trade/Device Name: Ahmed® Glaucoma Valve Model FP7 Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous shunt Regulatory Class: Class II Product Code: KYF Dated: March 28, 2023 Received: April 5, 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) K230975
Device Name Ahmed® Glaucoma Valve Model FP7
Indications for Use (Describe)
The Ahmed® Glaucoma Valve Model FP7 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, circular shape on the left, followed by the words "NEW WORLD" in a sans-serif font. Below "NEW WORLD" is the word "MEDICAL", with the letters spaced out more than the words above it.
510(K) SUMMARY - K230975
This 510(k) Summary has been prepared in accordance with 21 CFR 807.92
A. Date Prepared: 05/11/2023
B. Address and Registration
New World Medical, Inc. Submitter:
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. | Sterigenics U.S., LLC |
| 10763 Edison Court | 344 Bonnie Circle |
| Rancho Cucamonga, CA 91730 | Corona, CA 92880 |
| Phone: 909-466-4304 | |
| Fax: 909-466-4305 | |
| Contact Person: Victor Arellano | |
| FDA REGISTRATION#: 1000125279 | FDA REGISTRATION #: 2029275 |
Table 1: Manufacturer & Sterilization Information
C. Device Name
| Device Trade Name: | Ahmed® Glaucoma Valve Model FP7 |
|---|---|
| Common Name: | Glaucoma Drainage Device |
| Classification Name: | Aqueous Shunt (21 CFR 886.3920) |
| Product Code: | KYF |
| Device Class: | Class II - Ophthalmic Panel |
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D. Predicate Device
| 510 (K) Number: | K162060 |
|---|---|
| Device Name: | Ahmed ® Glaucoma Valve Model FP7 |
| Decision date: | 10/24/2016 |
E. Intended Use
The Ahmed® Glaucoma Valve Model FP7 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 FP7, 510(k) Number K162060
F. Device Description and Technological Characteristics
The Ahmed® Glaucoma Valve Model FP7 (AGV-FP7) (Modified) 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 mechanism. This valve mechanism is the same in the predicate AGV-FP7 (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 eye over the surface of the endplate. The valve in the AGV-FP7 (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
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Image /page/5/Picture/0 description: The image shows the logo for New World Medical. The logo consists of a green, abstract, circular design on the left, followed by the words "NEW WORLD" in a larger, sans-serif font. Below "NEW WORLD" is the word "MEDICAL" in a smaller, sans-serif font, with the letters spaced out.
Special 510(k) Ahmed® Glaucoma Valve Model FP7 (K230975)
mechanism, the AGV-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.
G. Proposed Change
The AGV-FP7 (modified) is a modification to the AGV-FP7 (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 FP7 (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.
I. Conclusion
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 FP7 (modified) described in this submission is substantially equivalent to the predicate device.