(69 days)
Not Found
No
The description focuses on the physical components and function of a laser probe and aspiration device, with no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is described as "an ophthalmic laser delivery device with aspirating capability" for "photocoagulation and aspiration" during "ophthalmic surgery." These actions directly treat a medical condition.
No
The device is described as an "ophthalmic laser delivery device with aspirating capability" used "during ophthalmic surgery for photocoagulation and aspiration." It facilitates a therapeutic procedure (photocoagulation and aspiration) rather than diagnosing a condition.
No
The device description clearly outlines multiple hardware components including a connector, silicone aspirating line, glass fiber, handpiece, stainless needle, and silicone sleeve.
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 Function: The description clearly states the device is an "ophthalmic laser delivery device with aspirating capability" used during ophthalmic surgery for photocoagulation and aspiration. It directly interacts with the patient's eye during a surgical procedure.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to deliver laser energy and aspirate material from the surgical site.
Therefore, this device falls under the category of a surgical instrument or therapeutic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
Product codes
HQF, HQE
Device Description
The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability. It consists of a connector that gets plugged into the Coherent/Alcon laser, a silicone aspirating line with female luer which attaches to an aspiration line associated with the operating system, a glass fiber with PVC jacket, a silicone reflux boot, a Delrin handpiece, a 304 stainless needle and silicone sleeve (soft tip) attached to the distal tip of the stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
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)
Not Found
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
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image is a black and white silhouette of a bird's head. The bird has a sharp, curved beak and a piercing eye. The bird's feathers are sleek and smooth, and its head is held high. The image is simple but striking, and it captures the power and grace of the bird.
JUN 2 1 2006
Peregrine Surgical Ltd. 51 Britain Drive New Britain, PA 18901
March 21, 2006
Premarket Notification [510(k)] Summary
Submitter: Peregrine Surgical Ltd. 51 Britain Drive New Britain, PA 18901 Phone: (215) 348-0456 (215) 348-5526 Fax:
Official Correspondent: Jayne Guthrie
Trade Name: Peregrine Soft Tip Aspirating Laser Probe
Common Name: Ophthalmic Aspirating Laser Probe
Registration Number: 2529392
Classification: Class II (Primary) Class II (Secondary)
Class Name: We were unable to find the device listed in the Disposable classification regulations, 21 CFR Parts 862-892 [807.87 (c)]
Panel: Ophthalmic
| Product Code: HQF (Primary) | HQE (Secondary) |
|---|---|
| Regulation Number: 21 CFR 886.4390 (Primary) | 21 CFR 886.4150 (Secondary) |
| Regulation Name: Ophthalmic Laser (Primary) | Vitreous aspiration and |
| cutting instrument. (Secondary) |
Device Description: The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability. It consists of a connector that gets plugged into the Coherent/Alcon laser, a silicone aspirating line with female luer which attaches to an aspiration line associated with the operating system, a glass fiber with PVC jacket, a silicone reflux boot, a Delrin handpiece, a 304 stainless needle and silicone sleeve (soft tip) attached to the distal tip of the stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
Statement of indications for use. -
For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
TEL: 215-348-0456 FAX: 215-348-5526 EMAIL: oph@peregrine-surgical.com
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Substantial Equivalence Comparison
| Application for 510K | Substantial Equivalence to: | Substantial Equivalence to: |
|---|---|---|
| Product PD720.60 | Aspirating Laser Probe | Infinitech Aspirating Laser Probe |
| Peregrine Soft Tip Aspirating | 510K K954308 | 510K K946135 |
| Laser Probe | Manufactured by Gamp & Assoc. | Manufactured by Infinitech |
| Light transmission for | Light transmission for | Light transmission for |
| photocoagulation | photocoagulation | photocoagulation |
| 905 SMA laser connector | 905 SMA laser connector | 905 SMA laser connector |
| Delrin Handpiece | Delrin Handpiece | Delrin Handpiece |
| Optical Fiber | Optical Fiber | Optical Fiber |
| Glass - Silica Core | Glass - Silica Core | Glass - Silica Core |
| .008" (200 microns) | .008" (200 microns) | .008" (200 microns) |
| Silicone aspirating line | Silicone aspirating line | Silicone aspirating line |
| Female connector | Female connector | Female connector |
| Silicone Reflux Boot | Silicone Reflux Boot | Silicone Reflux Boot |
| Silicone Soft Tip | Silicone Soft Tip | Silicone Soft Tip |
| PVC Jacket | PVC Jacket | PVC Jacket |
| Length 101 inches | Length 96 inches | Length 96 inches |
| 304 Stainless Needle | 304 Stainless Needle | 304 Stainless Needle |
| 20 Gauge | 20 Gauge | 20 Gauge |
| Max power output | Max power output | Max power output |
| 1 watt | 1 watt | 1 watt |
Sterility
:
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2006
Peregrine Surgical Ltd. c/o Theodore Richmond, Director of Product Development 51 Britain Dr. New Britain, PA 18901
Re: K061024
Trade/Device Name: Peregrine Soft Tip Aspirating Laser Probe, Model PD720.60 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF and HQE Dated: June 1, 2006 Received: June 5, 2006
Dear Mr. Richmond:
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.
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Page 2 - Mr. Theodore Richmond
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. Eychlenis MD
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
STATEMENT OF INDICATIONS FOR USE
510K Number (if known):
Device Name: Peregrine Soft Tip Aspirating Laser Probe
Indications for Use:
For use during ophthalmic surgery for photocoagulation and aspiration in conjunction with Coherent/Alcon laser and aspiration units. Laser wavelengths range from 193nm to 633nm.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ________xx
Over-The-Counter Use
Dezender 6/19/2006
Division Slan-Ophthalmic Ear
OR
510(k) Number K061024
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