(37 days)
The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.
The Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices. Inc. contains the identical same components and design as the device cleared under K110080 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it's a 510(k) premarket notification for a medical device (Radial-Emitting Shaped Fiber Optic Delivery System). The key takeaway from the "Performance Data" section (Page 1) is:
"Since the performance of the Radial-Emitting Shaped Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission."
This statement indicates that the submission relies on the established performance of a predicate device (K110080) and asserts that the new device has "identical same components and design" and "no differences in technology." Therefore, it raises no "new questions on safety or efficacy" and is considered "substantially equivalent" to the predicate device.
Given this, I cannot fill out the requested table or answer most of your detailed questions about acceptance criteria and a study.
However, I can extract what limited information is available related to the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified. The submission states that performance is "well established and documented on soft tissue" for the predicate device. | The device has "identical same components and design as the device cleared under K110080" (the predicate device). It has "no differences in technology" and is "as safe and effective" as the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not applicable. No new performance testing was conducted for this submission.
- Data provenance: Not applicable. The submission relies on the established performance of a predicate device, but no specific data or its provenance is detailed.
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)
- Not applicable. No new performance testing was conducted that would require establishing ground truth by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance testing was conducted.
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. This device is a fiber optic delivery system, not an AI or imaging device involving human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (fiber optic delivery system), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new performance testing or ground truth establishment was conducted for this submission. The submission relies on the performance of a predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
In summary, this 510(k) submission leverages the concept of "substantial equivalence" to a predicate device. It explicitly states that no new performance testing was conducted or included in the submission because the device is identical in components and design to a previously cleared device, and its performance is considered "well established."
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SEP 3 0 2011
K112442..
510(k) Summary Radial-Emitting Shaped 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 Phone: (413) 525-0600 Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. – Regulatory Consultant Date prepared: August 16, 2011
Name of Device and Name/Address of Sponsor
Radial-Emitting Shaped Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser accessory
Predicate Devices
Radial-Emitting Shaped Fiber Optic Delivery System, (K110080)
Intended Use/Indication for Use
The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.
Technological Characteristics
The Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices. Inc. contains the identical same components and design as the device
GBDA/ BioMD-RF-DL-081611-04
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cleared under K110080 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
Performance Data
Since the performance of the Radial-Emitting Shaped 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 Radial Emitting Shaped Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc Radial-Emitting Shaped Fiber Optic Delivery System. Thus, the Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.
. ·
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of a human figure with three flowing lines above it, all enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolitec Medical Devices, Inc. % Harry Haves, Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028
SEP 3 0 2011
Re: K112442
Trade/Device Name: Radial-Emitting Shaped Fiber 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: August 16, 2011 Received: August 24, 2011
Dear Dr. Haves:
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.
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
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Page 2 - Harry Haves, Ph.D.
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 (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/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/ReportaProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
< 11 2442 510(k) Number (if known):
:
Device Name: Radial-Emitting Shaped Fiber Optic Delivery System
The Radial Emitting Shaped Fiber Optic Delivery Indications for Use: System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.
(PLEASE DO NOT WRITE BELOW THIS LINE … CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Sdl for men
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112442
Prescription Use _ V (Per 21 C.F.R. 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
GBDA/ BioMD-RF-DL-081611-04
Page 36
§ 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.