(43 days)
The ProXenon 350 Light Source is designed for use with fiber optic, headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures.
The Welch Allyn ProXenon 350 Fiber Optic Surgical Illuminator is designed for use with fiber optic headlight systems. The ProXenon 350 Fiber Optic Surgical Illuminator uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams. The Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiber optic cables. Each port is readily identified on the turret perimeter. The ProXenon 350 system consists of 3 major components; a 300W Xenon light source, a fiber optic bundle, a headlight consisting of a luminaire (contains optics to focus and direct the illumination) and a headband. The surgeon uses the headlight to provide auxiliary illumination when performing surgical procedures. The headlight is especially useful for illumination of deep body cavities since it provides shadow free illumination.
This Welch Allyn ProXenon 350 submission is for a surgical illuminator, which is a hardware device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way one would for a diagnostic or AI-driven medical device. Therefore, much of the requested information regarding "acceptance criteria and reported device performance" in terms of clinical metrics (like sensitivity, specificity, etc.), sample sizes for test sets, expert-established ground truth, and AI-specific study types (MRMC, standalone algorithm performance) is not applicable or present in this document.
However, I can extract the relevant information from the provided text based on the nature of this submission.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
For a hardware device like a surgical illuminator, acceptance criteria and performance are typically related to engineering specifications, safety standards, and functional equivalence. These are usually established internally by the manufacturer and demonstrated through testing, rather than presented as clinical performance metrics in a 510(k) summary. The document states that the ProXenon 350 "uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams." The performance goal is to provide "supplemental light for surgical and medical procedures" and "shadow free illumination" especially in deep body cavities. The acceptance criteria would likely be met through engineering tests ensuring brightness, beam uniformity, heat dissipation, and compatibility with various fiber optic cables. Since this is a 510(k) summary, these granular engineering details are not included.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (From Description) |
|---|---|
| Light Source Intensity | Uses a "high-intensity ... xenon short arc lamp". |
| Beam Profile | "fixed internal reflector to produce a uniform profile beams". |
| Intended Use Fulfillment | Provides "supplemental light for surgical and medical procedures." "Especially useful for illumination of deep body cavities since it provides shadow free illumination." |
| Compatibility | "Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiber optic cables." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the context of this 510(k) for a physical medical device. Performance testing for a surgical illuminator typically involves engineering and safety evaluations, not data-driven clinical studies with test sets in the typical sense of AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. Ground truth, in the context of expert review, is typically relevant for diagnostic devices that interpret images or other patient data. A surgical illuminator is a tool; its "performance" isn't assessed by expert interpretation of its output in a clinical ground truth setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in studies involving subjective interpretation, often in clinical trials or diagnostic accuracy studies, which are not detailed in this 510(k) summary for a surgical illuminator.
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 and not provided. MRMC studies are specific to diagnostic performance, particularly for AI applications, and are entirely outside the scope of a 510(k) for a basic surgical illuminator. There is no AI involved in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a hardware illuminator; there is no algorithm or AI component to perform in "standalone" mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. For a surgical illuminator, "ground truth" as a clinical reference standard is not a relevant concept for demonstrating its safety and effectiveness. Its function is direct illumination, not diagnosis or data interpretation.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used for machine learning models, which are not part of this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As above, ground truth for training data is not relevant to a hardware surgical illuminator.
Summary of the 510(k) information provided:
The provided document is a 510(k) Premarket Notification for the Welch Allyn ProXenon 350, a fiber optic surgical illuminator. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (the Isolux Fiber Optic Surgical Headlight System, K991572). This type of submission primarily focuses on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
Key aspects highlighted in the submission regarding the device's characteristics and intended function:
- Intended Use: The ProXenon 350 Light Source is designed for use with fiber optic headlight systems to provide supplemental light for surgical and medical procedures, particularly useful for "shadow free illumination" in deep body cavities.
- Technological Characteristics: It uses a high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector for uniform illumination. It features a four-port turret compatible with Wolf, Storz, Olympus, and ACMI fiber optic cables.
- Predicate Device: Isolux Fiber Optic Surgical Headlight System (K991572).
Since this is a Class II device and a 510(k) submission for a non-AI hardware device, the documentation focuses on engineering specifications, safety, and functional equivalence rather than clinical performance data in the form of sensitivity/specificity or AI-specific study designs.
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Welch Allyn
Traditional 510(k) Premarket Notification ProXenon 350
Premarket Notification [510(k)] Summary 5. Submitted By: Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 JUN 1 4 2007 Phone: (315) 685-4571 Fax: (315) 685- 2532 Contact: John E. Sawyer, Vice-President, Quality Assurance & Regulatory Affairs light, surgical, fiberoptic Common Name: Trade Name: ProXenon 350 Classification: Class II; 21 CFR § 878.4580, General & Plastic Surgery Predicate Device: The Isolux Fiber Optic Surgical Headlight System with 510(k) number K991572 Description: The Welch Allyn ProXenon 350 Fiber Optic Surgical Illuminator is designed for use with fiber optic headlight systems. The ProXenon 350 Fiber Optic Surgical Illuminator uses a Welch Allyn high-intensity, narrow-beam, rugged xenon short arc lamp with a fixed internal reflector to produce a uniform profile beams. The Four Port Turret accepts Wolf, Storz, Olympus, and ACMI fiber optic cables. Each port is readily identified on the turret perimeter. The ProXenon 350 system consists of 3 major components; a 300W Xenon light source, a fiber optic bundle, a headlight consisting of a luminaire (contains optics to focus and direct the illumination) and a headband. The surgeon uses the headlight to provide auxiliary illumination when performing surgical procedures. The headlight is especially useful for illumination of deep body cavities since it provides shadow free illumination. Intended Use: The ProXenon 350 Light Source is designed for use with fiber optic headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation. Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures.
Section 5 - Page 1 of 1 This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.
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Image /page/1/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 pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Welch Allyn, Inc. % Mr. Chris Horacek Vice President Chief Compliance Officer 4341 State Street Road P.O. Box 220 Skaneateles Falls, New York 13153-0220
JUN 1 4 2007
Re: K071218
Trade/Device Name: ProXenon 350 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: June 7, 2007 Received: June 12, 2007
Dear Mr. Horacek:
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
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Page 2 - Mr. Chris Horacek
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.
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,
For
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WelchAllyn
Traditional 510(k) Premarket Notification ProXenon 350
- Statement of Indications For Use
510(k) Number (if known):
Device Name: ProXenon 350
Indications For Use:
The ProXenon 350 Light Source is designed for use with fiber optic, headlight systems. It will accept fiber optic light guides for Wolf, Storz, Olympus and ACMI instrumentation.
Accessory Headlight is a passive luminaire that is illuminated by fiber optic light and utilized to provide supplemental light for surgical and medical procedures.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L01128
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
MPD FCD-0024, Rev. 3
Section 4 - Page 1 of 1
This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.