(85 days)
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
The Kelsey Interstitial Laser Therapy system consists of the following:
- One laser probe, a 14 gauge needle, 304 stainless steel with one (1) thermistor attached.
- One temperature probe, a 14 gauge needle, 304 stainless steel with five (5) thermistors attached.
- Thermistor temperature to digital converter.
- Syringe infusion pump capable of accurately infusing a normal saline solution at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function.
- Laser diode source, 1-8 watts, 805 nominal nanometer wavelength.
- Storage cart.
- Personal computer running Windows XP with Service Pack 2, or better, including monitor and keyboard.
The provided text is a 510(k) summary for the Kelsey Interstitial Laser Therapy System. It describes the device, its intended use, and its comparison to predicate devices, focusing on the regulatory approval process rather than detailed performance study results.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available within the provided document. The 510(k) summary states that "Bench and clinical testing demonstrated that the use of the Kelsey ILT device for the ablation of breast fibroadenoma tissue is safe and effective," but it does not provide the specifics of these tests or their results in a format that would allow for the detailed table and answers requested.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not specify quantitative acceptance criteria or provide specific reported device performance metrics in a verifiable way. It only broadly states that testing "demonstrated that the use of the Kelsey ILT device for the ablation of breast fibroadenoma tissue is safe and effective."
2. Sample size used for the test set and the data provenance
Not available. The document mentions "clinical testing" but does not provide details on the sample size of any test set, nor does it specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available. There is no mention of experts establishing ground truth or their qualifications.
4. Adjudication method for the test set
Not available. The document does not describe any adjudication method.
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
Not applicable. The Kelsey Interstitial Laser Therapy System is a surgical instrument using laser therapy, not an AI-assisted diagnostic or imaging device for human readers. Therefore, an MRMC comparative effectiveness study would not be relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As stated above, this device is a surgical instrument, not an algorithm, so this question is not relevant.
7. The type of ground truth used
Not available. While "ablation of breast fibroadenoma tissue" implies a clinical outcome, the specific type of ground truth (e.g., pathology, clinical follow-up, imaging correlation) used to assess the device's "safety and effectiveness" is not detailed.
8. The sample size for the training set
Not applicable/Not available. As above, this is a surgical instrument, not a device involving machine learning algorithms that would typically have a "training set." If "training set" refers to pre-clinical or bench testing, the sample size is not provided.
9. How the ground truth for the training set was established
Not applicable/Not available. As above, this question is not relevant in the context of the device described.
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Kelsey, Inc. 510(k) Submission - ILT January 31, 2007
3 510k Summary
3.1 Company
Kelscy, Inc. 20 South Clark Street, Suite 1600 Chicago, IL 60603
3.2 Contact
Paul Ketteridge Regulatory Consultant to Kelsey 303 Patleigh Rd Catonsville, MD 21228 (443) 729-0836 Voice (443) 729-0826 Fax p.kett(a)comcast.net
3.3 Date Prepared
January 24, 2007
3.4 Device Name
| Trade Name: | Kelsey Interstitial Laser Therapy System |
|---|---|
| Classification Name: | Laser powered surgical instrument |
3.5 Predicate Devices
| Diomed 15 Plus | |
|---|---|
| Indigo 830 | |
| Indigo Diffuser Tip Fiberoptic w/Temp Sensing Option | |
| Cryocarc™ Surgical System |
3.6 Device Description
The Kelsey Interstitial Laser Therapy system consists of the following:
- One laser probe, a 14 gauge needle, 304 stainless steel with one (1) thermistor attached. 트
- 트 One temperature probe, a 14 gauge needle, 304 stainless steel with five (5) thermistors attached.
- 제 Thermistor temperature to digital converter.
- . Syringe infusion pump capable of accurately infusing a normal saline solution at variable flow rates to 1 cc per minute, continuously adjustable, including bolus function.
- . Laser diode source, 1-8 watts, 805 nominal nanometer wavelength.
- 해 Storage cart.
MAY - 2 2007
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Kelsey, Inc. 510(k) Submission - ILT January 31, 2007
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- . Personal computer running Windows XP with Service Pack 2, or better, including monitor and keyboard.
3.7 Intended Use
The intended use for the Kelsey Interstitial Laser Therapy System is the predicate devices. Its intended use is as a surgical instrument in the excision of external tumors and lesions, complete and partial resection of internal organs, treatment of tumors and lesions, skin incision and tissue dissection and ablation.
3.8 Indications for Use
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for gencral surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
3.9 Comparison of Technological Characteristics
The Kelsey Interstitial Laser Therapy System is a self-contained surgical lascr that generates near-infrared laser radiation. A fiber optic delivery system is coupled to the laser to deliver laser radiation to the target tissue. These technologic characteristics are shared with the previously identified predicate devices.
3.10Performance Data
Bench and clinical tcsting demonstrated that the use of the Kelsey ILT device for the ablation of breast fibroadenoma tissue is safe and effective.
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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kelsey, Inc. % Mr. Paul Ketteridge Regulatory Consultant 303 Patleigh Road Catonsville, Maryland 21228
MAY - 2 2007
Re: K070353
Trade/Device Name: Kelsey Interstitial Laser Therapy System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 31, 2007 Received: February 6, 2007
Dear Mr. Ketteridge:
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. Paul Ketteridge
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,
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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Kelsey, Inc. 510(k) Submission - ILT January 31, 2007
Indications for Use 2
510(k) Number (if known): K070353
Device Name: Kelsey Interstitial Laser Therapy System
Indications for Use:
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
Prescription Use (21 CFR 801 Subpart D) X
And/Or
Over-The-Counter Use (21 CFR 807 Subpart C)
Do Not Write Below This Line – Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dehn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number L070353
Page 7
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.