(168 days)
Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.
This device is constructed from an Exmoor Single Use Suction Tube (MP17291), 510K 892504, a piece of stainless steel needle tubing (MP170288) identical to that used in MP170291, covered by the same 510K 892504, and a piece of silicone rubber tubing (MP180163) which is used to hold the two pieces of stainless steel tubing together in the correct position. It uses locally supplied suction tubing to connect the device to suction by pushing the tubing over the ball feature at the proximal end of the handle. The laser fibre is passed down the exposed end of the stainless steel tubing adjacent to the handle until it emerges from the distal end. The laser fibre protruding from the distal end of the instrument should be stripped and cleaved and adjusted to the required length.
The provided document is a 510(k) premarket notification for a medical device called "Dilkes Laser/Suction Cannulae". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is generally not part of a 510(k) submission unless there are specific performance claims that require such data.
Based on the provided text, I can extract the following relevant information and infer the absence of the requested study details:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a formal study reporting direct device performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the device is as safe and effective as the predicate devices for its intended use.
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
These points are not applicable to this 510(k) submission. A 510(k) mainly relies on a comparison of technological characteristics, materials, and intended use with existing legally marketed devices, rather than a clinical trial demonstrating performance against specific metrics or involving human readers/AI. There is no mention of a clinical study, test set, ground truth experts, or comparative effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As no clinical study is described, there is no "ground truth" established in this context. The demonstration of safety and effectiveness relies on the comparison with predicate devices.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is not an AI/ML algorithm that requires a training set with established ground truth.
Summary of what the document does provide regarding the device and its clearance:
- Device Name: Dilkes Laser/Suction Cannulae
- Intended Use: Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.
- Predicate Devices:
- House Suction/Irrigation Tube 55-0207, manufactured by Richards
- Microstat hand-piece from Laserscope
- Comparison with Predicate Devices (Basis for Substantial Equivalence):
- Size of the Dilkes Laser/Suction Cannulae is very similar to the House Suction/Irrigation Tube.
- One predicate device (Microstat hand-piece) is currently being used for suction/Laser delivery, implying the combined function is already marketed.
- Materials are similar (stainless steel in both cases).
- The handle of the subject device is polyethylene (single-use), while the predicate is re-usable, which is a material difference but likely considered acceptable for a single-use device.
- Regulatory Outcome: The FDA determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, allowing it to be marketed.
In essence, the "study" demonstrating this device meets criteria is a substantially equivalent comparison to existing devices, not a clinical performance study with quantitative acceptance criteria.
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SEP 1 4 1998
( lontract: Margaret Blackmore
4 September 1998.
Ref: K981143
SUMMARY OF SAFETY AND EFFECTIVENESS
| Trade Name: | Dilkes Laser/Suction Cannulae |
|---|---|
| Common Name: | Twin Channel Suction Tube |
| Classification Name: | Unknown |
| Predicate Devices: | 1. House Suction/Irrigation Tube 55-0207, manufactured by Richards,2. Microstat hand-piece from Laserscope |
| Description of Device: | This device is constructed from an Exmoor Single Use Suction Tube (MP17291), 510K 892504, a piece of stainless steel needle tubing (MP170288) identical to that used in MP170291, covered by the same 510K 892504, and a piece of silicone rubber tubing (MP180163) which is used to hold the two pieces of stainless steel tubing together in the correct position. It uses locally supplied suction tubing to connect the device to suction by pushing the tubing over the ball feature at the proximal end of the handle. The laser fibre is passed down the exposed end of the stainless steel tubing adjacent to the handle until it emerges from the distal end. The laser fibre protruding from the distal end of the instrument should be stripped and cleaved and adjusted to the required length. |
| Intended Use: | Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke. |
| Comparison with Predicate Devices: | The size of the House Suction/Irrigation Tube is very similar to the Dilkes Laser/Suction Cannulae.The predicate device is currently being used for suction/Laser delivery.The materials are similar in that stainless steel is used in both cases. The handle of the subject device is polyethylene, as this is a single - use device. The predicate device is re-usable. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Ms. Margaret Blackmore Regulatory Affairs Administrator Exmoor Plastics Limited Lisieux Way Taunton, TA1 2LB, U.K.
Re: K981143 Trade Name: Dilkes Laser/Suction Cannulae Regulatory Class: II Product Code: GEX Dated: August 5, 1998 Received: August 11, 1998
Dear Ms. Blackmore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Margaret Blackmore
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________DILKES LASER/SUCTION CANNULAE
Indications for Use:
Any surgical procedure within the nasal cavity, the oral cavity or the Any surgical procedure within the nasar surgery and suction capability to remove smoke.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
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Division of General Restorative Devices K98511(Division Sign-Om)
Division of General Restorative Devices K981143
510(k) Number
Prescription Use_ (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.