(69 days)
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.
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."
The provided document is a 510(k) Premarket Notification for the Peregrine Soft Tip Aspirating Laser Probe. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these documents.
Here's the information that can be extracted or deduced from the provided text, along with an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria for novel safety and effectiveness endpoints. The document lists comparative characteristics to predicate devices, but these are not presented as acceptance criteria for specific performance metrics of the new device.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable/provided. The 510(k) submission does not describe a clinical study with a "test set" in the context of evaluating performance against acceptance criteria. The comparison is based on device characteristics and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/provided. As no clinical study or test set for performance evaluation is described, there's no mention of experts establishing ground truth for such a study.
4. Adjudication Method for the Test Set
This information is not applicable/provided. No test set and associated adjudication method are described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an ophthalmic laser delivery and aspiration probe, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study or AI-related effectiveness analysis is irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a medical instrument, not an algorithm.
7. The type of ground truth used
This information is not applicable/provided. No specific ground truth establishment for performance evaluation is discussed since it's a 510(k) submission for a device, not a diagnostic algorithm. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. As it's a physical medical device and not an AI/algorithm, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided. As there is no training set, there's no ground truth establishment for it.
Summary of Relevant Information from the Document:
While the document doesn't provide the requested study design details, it demonstrates the basis for its substantial equivalence claim, which is the regulatory standard for a 510(k) submission.
- Device Description: The Peregrine Soft Tip Aspirating Laser Probe is an ophthalmic laser delivery device with aspirating capability, consisting of a connector, silicone aspirating line, glass fiber with PVC jacket, silicone reflux boot, Delrin handpiece, 304 stainless needle, and silicone sleeve (soft tip).
- 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.
- Substantial Equivalence Basis: The device is compared to two predicate devices: "Aspirating Laser Probe" (K954308, Manufactured by Gamp & Assoc.) and "Infinitech Aspirating Laser Probe" (K946135, Manufactured by Infinitech). The comparison table highlights similarities in:
- Light transmission for photocoagulation
- 905 SMA laser connector
- Delrin Handpiece
- Optical Fiber (Glass - Silica Core, .008" / 200 microns)
- Silicone aspirating line
- Female connector
- Silicone Reflux Boot
- Silicone Soft Tip
- PVC Jacket
- 304 Stainless Needle (20 Gauge)
- Max power output (1 watt)
- One difference noted is the length: Peregrine's device is 101 inches, while predicates are 96 inches.
- Sterilization: The device will be ETO Sterilized, validated using the AAMI Overkill Method.
The FDA's letter on page 2 confirms that the agency "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is the "proof" that the device meets the regulatory requirements for market entry under a 510(k), based on its similarity to already approved devices.
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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 andcutting 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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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
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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
Page 3
§ 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.