(17 days)
The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System consists of quartz fiber core and a coaxially mounted protective sheath with a metal tin at the distal end.
The provided document is a 510(k) summary for the Biolitec MegaBeam® SideFiber® Fiber Optic Delivery System, which is a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria for device performance as would be seen for new, high-risk devices.
Therefore, the document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI.
Instead, the submission relies on bench test data and the demonstration of substantial equivalence to legally marketed predicate devices.
Here's a breakdown of what can be extracted from the document based on your request, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Bench test data was provided in support of the 510(k) notice." However, the specific acceptance criteria and the quantitative results of these bench tests are not included in this public summary. The summary concludes that the device is "as safe and effective" as its predicate based on these tests and other characteristics, but doesn't quantify this performance against explicit acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "bench test data," which implies laboratory testing rather than human subject data or a clinical "test set." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for any testing.
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)
- Cannot be provided. Since no clinical test set or human subject data is described, there's no mention of experts establishing a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set means no 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
- Cannot be provided. This device is a fiber optic delivery system, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This question is relevant for AI algorithms. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. Given the nature of a fiber optic delivery system and the reliance on bench testing for a 510(k), ground truth in the sense of clinical diagnostic accuracy (e.g., pathology) is not applicable. The "ground truth" for bench tests would relate to engineering specifications and physical measurements (e.g., power output, fiber integrity, heat dissipation) compared to specified design parameters or predicate device performance. These specifics are not detailed in the summary.
8. The sample size for the training set
- Cannot be provided. This question is relevant for AI algorithms. The device is a physical medical instrument, not an algorithm, and therefore does not have a "training set" in this context.
9. How the ground truth for the training set was established
- Cannot be provided. This question is relevant for AI algorithms. Not applicable to this device.
Summary of Device Performance (Based on provided text):
The 510(k) summary primarily asserts "Substantial Equivalence" to predicate devices rather than providing detailed performance metrics against specific acceptance criteria.
Acceptance Criteria & Reported Performance Table (as much as can be inferred):
| Acceptance Criterion (Inferred from 510(k) process) | Reported Device Performance (Summary Statement) |
|---|---|
| Safety and Effectiveness (equivalent to predicate) | The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is as safe and effective as the Biolitec MegaBeam Lateral Fiber (SideFiber) Fiber Optic Delivery System (predicate). |
| Intended Uses (matching predicate) | Has the same intended uses as its predicate device. |
| Indications for Use (similar to predicate) | Has similar ... indications as its predicate device. |
| Technological Characteristics | Has similar technological characteristics and principles of operation as its predicate device. |
| No New Safety/Effectiveness Issues | The minor technological differences ... raise no new issues of safety or effectiveness. |
In conclusion, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the kind of detailed performance metrics, acceptance criteria, or clinical study data that would be present for a novel diagnostic device or AI algorithm, which typically requires a different regulatory pathway or more extensive clinical evidence.
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JAN 2 3 2006
Kobouso 510(k) SUMMARY
Biolitec MegaBeam® SideFiber® Fiber Optic Delivery System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec, Inc 515 Shaker Road EastLongmeadow, MA 01028
Phone: (413) 525 0600 Facsimile: (413) 525 0611
Contact Person: Carol J. Morello, VMD
Date Prepared: January 6, 2006
Name of Device
MegaBeam SideFiber Fiber Optic Delivery System (Model SF-2100-H)
Common or Usual Name
Ho:YAG Fiber Optic Delivery System
Classification Name
Accessory to Laser Surgical Instruments
Predicate Devices
Biolitec Inc MegaBeam Lateral Fire Fiber Optic Delivery System Lumenis DuoTome Side Firing Fiber Trimedyne VAPORMAX side firing fiber
Intended Use / Indications for Use
The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissued in discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
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Kobooso
Technological Characteristics
The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System consists of quartz fiber core and a coaxially mounted protective sheath with a metal tin at the distal end.
Performance Data
Bench test data was provided in support of the 510(k) notice.
Substantial Equivalence
The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is as safe and effective as the Biolitec MegaBeam Lateral Fiber (SideFiber) Fiber Optic Delivery System. The MegaBeam Lateral Fiber Optic Delivery System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the MegaBeam Fiber Optic Delivery System and it 2 predicate devices raise no new issues of safety or effectiveness. Thus, the MegaBeam Fiber Optic Delivery System is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2006
Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan and Hartson, L.L.P. 555 13th Street, NW Washington, District of Columbia 20004-1109
Re: K060050
Roodo50
Trade/Device Name: MegaBeam SideFiber Fiber Optic Delivery System (Model SF-2100-H) 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 6, 2006 Received: January 6, 2006
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the Merce, 1976, the enactment date of the Medical Device Amendments, or to conimeres prior to May 20, 1978) 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). and Cosmetter Free) the device, subject to the general controls provisions of the Act. The r ou may, and every inions 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 cormply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 — Mr. Kahan
(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.
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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Mielup
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
12660050 510(k) Number (if known):
Device Name:
Indications for Use:
The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorhare Budhur for mam
sion Sign-O Division of General, Restorative, and Neurological Devices
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510(k) Number K060050
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§ 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.