(71 days)
The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode 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 Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it describes a 510(k) submission for a medical device (Twister™ Side-Firing Fiber Optic Delivery System) and states that no specific performance testing was included because its performance on soft tissue is "well established and documented."
Therefore, most of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document explicitly states: "Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission." This indicates that no new performance data or acceptance criteria for this specific submission were presented or needed due to relying on prior established performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new test set data was included in this submission.
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. No new test set data was included in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No new test set data was included in this submission.
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-powered diagnostic tool, so an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a fiber optic delivery system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. No new performance study generating ground truth was conducted for this submission. The submission relies on "well established and documented" performance of similar predicate devices, implying that any ground truth would have been established during the development and clearance of those previous devices.
8. The sample size for the training set
- Cannot be provided. This device is a physical delivery system, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Cannot be provided. Same as above, no training set applies.
Summary from the provided text:
The submission for the Twister™ Side-Firing Fiber Optic Delivery System is based on substantial equivalence to existing predicate devices (Megabeam® Lateral/ Side Fire Fiber Optic Delivery System). The core argument is that the Twister system has "equivalent components and identical patient-contact materials" and its "performance... on soft tissue is well established and documented." Therefore, no new performance testing or specific studies were included in this submission to demonstrate acceptance criteria for this particular device. The acceptance criteria are implicitly met by its substantial equivalence to previously cleared devices whose performance was already deemed acceptable.
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12987
DEC 1 6 2011
510(k) Summary Twister™ Side-Firing Fiber Optic Delivery System
Submitter's Name. Address. Telephone Number, Contact Person and Date Prepared Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: October 5, 2011
Name of Device and Name/Address of Sponsor
Twister™ Side-Firing Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser & accessories
Predicate Devices
Megabeam® Lateral/ Side Fire Fiber Optic Delivery System, (K940008, K941909, K943444, K943526, K943527 and K060050)
Intended Use/Indication for Use
The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode 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.
Technological Characteristics
The Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.
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Performance Data
مَرَ.. - -
Since the performance of the Twister™ Side-Fire Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.
Substantial Equivalence
The Twister™ Side-Fire Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc MegaBeam® Lateral/ Side Fire Fiber Optic Delivery System. Thus, the Twister™ Side Fire Fiber Optic Delivery System for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.
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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 eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2011
Biolitec Medical Device, Incorporated % Genmarhay, BDA Harry Hayes, Ph.D. Regulatory Consultant . 1349 Main Road Grandville, Massachusetts 01034
Re: K112987
Trade/Device Name: Twister™ Side-Firing Optic Delivery System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 5, 2011 Received: October 6, 2011
Dear Dr. Hayes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Harry Hayes, Ph.D.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeviccs/ResourcesforYou/Industry/default.htm.
Sincerely yours,
fon Neth Lundi
Mark N. Melkerson Director . Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): k|12687
Device Name:
Twister™ Side-Firing Fiber Optic Delivery System
Indications for Use:
The Twister™ Side Firing Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any surgical laser with SMA 905 compatible connector. The Twister™ Side-Firing Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode 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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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 C.F.R. 801.109) OR
Over The Counter Use (Optional Format 1-2-96)
Nielae Ogden for mkm
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112987
GBDA/ BioELVeS-060710-02
Page 37
§ 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.