(22 days)
The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 or SMA 905 compatible connectors. In addition cleared lasers with SMA 906 connectors.
The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors. MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.
MED-Fibers surgical laser delivery system fibers contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be used with hand pieces. MED-Fibers surgical laser delivery system fibers has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 550, 600, 800 and 1000 microns) are offered.
The device described, MED-Fibers Surgical Laser Fibers, is a fiber optic laser delivery system intended for various surgical applications. Based on the provided 510(k) summary, specific acceptance criteria and a detailed study proving the device meets them are not provided.
Instead, the submission relies on substantial equivalence to predicate devices. The key argument for safety and effectiveness is that the MED-Fibers surgical laser delivery system operates in the same manner and has the same technical characteristics as established predicate devices, and therefore does not raise new questions of safety or efficacy.
Here's an analysis of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or thresholds. The implicit acceptance criterion is "substantial equivalence" to predicate devices, meaning it performs comparably and safely. | The device "operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices." (Qualitative statement) |
2. Sample Size Used for the Test Set and Data Provenance
Performance data from specific test sets is not provided. The submission states, "The performance of the MED-Fibers surgical laser fiber delivery systems is well established and documented so no performance testing is included." This implies a reliance on the historical performance of similar predicate devices rather than a new independent study with a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no new performance testing with a specific test set requiring ground truth establishment was conducted or reported.
4. Adjudication Method for the Test Set
Not applicable, as no new performance testing with a specific test set or associated adjudication was conducted or reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not conducted or mentioned. This device is a physical laser delivery system, not an algorithm or AI.
7. The Type of Ground Truth Used
Not applicable, as no new performance testing was conducted. The "ground truth" for this type of submission is typically derived from the well-established safe and effective use of the predicate devices in clinical practice by qualified medical professionals.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (laser fiber delivery system), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant for this device.
Summary of the Study and Evidence Presented:
The submission for the MED-Fibers Surgical Laser Fibers is a 510(k) premarket notification based on the concept of substantial equivalence. Rather than presenting a new clinical or performance study with defined acceptance criteria and data, the manufacturer asserts that their device is substantially equivalent to several legally marketed predicate devices.
The justification for this substantial equivalence is rooted in:
- Identical intended use/indications for use.
- Same technological characteristics: The device uses the same materials (silica for fiber core and cladding) and operates in the same manner as predicate devices.
- No new questions of safety or efficacy: Because the technology is deemed identical and well-established, no new risks or performance concerns are raised.
Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the FDA's review and concurrence that the device's technical characteristics and intended use align sufficiently with predicate devices that have a history of safe and effective use. The acceptance criteria are, in essence, the FDA's regulatory requirements for establishing substantial equivalence for this specific class of device.
§ 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.