(88 days)
Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
The Light Saber Introducer Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.
The provided text, K013040 for the MINRAD, INC. Light Saber™ Introducer Needle, is a 510(k) summary and FDA clearance letter. It does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving a device meets those criteria, particularly for a device that relies on complex performance metrics like an AI/ML algorithm.
The Light Saber™ Introducer Needle is a physical medical device designed to gain percutaneous access for surgical procedures, and specifically to be used with a Dual Radiation Targeting System (DRTS) to improve needle placement accuracy.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable in the context of this 510(k) submission for this type of device. The FDA clearance for this device, as indicated in the provided documents, is based on substantial equivalence to predicate devices, not on a clinical study demonstrating performance against specific numerical acceptance criteria for an AI/ML algorithm.
However, I can still extract relevant information about the device and its clearance process:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds. For substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to predicate devices.
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) akin to those for AI/ML algorithms are reported. The document states:
- "The Light Saber Introducer Needle is identical to a combination of its predicate devices."
- "These minor differences raise no new issues of safety or effectiveness."
- "Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not describe a clinical test set of real-world cases with associated data for an AI/ML algorithm. The equivalence is based on design comparison and intended use, not statistical performance on a dataset.
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. Ground truth establishment by experts for a test set is not part of a substantial equivalence submission for a physical introducer needle.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process as described for AI/ML algorithms is mentioned.
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. No MRMC study was conducted or reported for this device. The device itself is an introducer needle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical introducer needle; there is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this submission. The "ground truth" for substantial equivalence is the existing regulatory classification and safety/effectiveness profile of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no AI/ML algorithm involved, so no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment process as described for AI/ML algorithms is mentioned.
In summary: The provided 510(k) summary for the MINRAD, INC. Light Saber™ Introducer Needle focuses on demonstrating substantial equivalence to existing predicate devices based on design, intended use, and technological characteristics. It does not involve performance studies or data analysis in the way modern AI/ML medical devices require, as it is a physical surgical tool.
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EXHIBIT A - 510(K) SUMMARY MINRAD, INC. LIGHT SABER™ INTRODUCER NEEDLE
DEC 0 7 2001
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MINRAD, INC. 847 Main Street Buffalo, NY 14203
Phone: (716)-855-1068 Facsimile: (716)-855-1071
Contact Person: John Riggi Director, Regulatory Affairs August 29, 2001 Date Prepared:
Name of Device and Name/Address of Sponsor
Light Saber™ Introducer Needle
MINRAD, INC. 847 Main Street Buffalo, NY 14203
Common or Usual Name
Surgical Guide Needle/General and Plastic Surgery, Cannula
Classification Name
Surgical Guide Needle/General and Plastic Surgery, Cannula
Predicate Devices
-
- Introducer Needle Accessory, Oratec Interventions, Inc.
-
- Light SaberTM Aspiration Needle, MINRAD, Inc.
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EXHIBIT A - 510(K) SUMMARY MINRAD, INC. LIGHT SABER™ INTRODUCER NEEDLE (cont.)
Intended Use
The Light Saber™ Introducer Needle is intended to be a single use disposable The Light Daber introducer needler.amidia micentisa intenducer Needle is generally non-vascular procedures: - The Esgle starter.
indicated to gain percutaneous access to the body for surgical procedures and mulcated to gain percultures with the DRTS to improve the accuracy of needle placement.
Technological Characteristics
Iological Onaraover Ibereo Needle consists of a needle, a collimator, to which The fight Saber Introducer Neves enclosed in a cannula/hub assembly with a a soyieving tip. The female Luer of the cannula hub, for attachment to the mateling op. The 10to comply with ISO-594 for "Conical fittings with a 6% Syringe, is debigited to ossings of ther medical equipment." The Light (Duer) tor by inges) installer are provided in gauges of 17, 18, and 19 and in Daber - Invodated 11 Sinches. The tip design for these needles will provide icities of 27x, I all a point. Depth markings are standard on the cannula at 1cm intervals.
Substantial Equivalence
The MINRAD, INC. Light Saber™ Introducer Needle is substantially The MINI-a-13, 11. 01 he currently marketed devices, which are referenced equivalent to the other odifferences in general indications for use, size of the abover and needle tip configurations, the MINRAD, INC. Light Saber™ Introducer Needle is identical to a combination of its predicate devices. These minor differences raise no new issues of safety or effectiveness. Thus, the MINRAD, INC. Light Saber™ Introducer Needle is substantially equivalent to its predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Riggi Director, Regulatory Affairs MINRAD, Inc. 847 Main Street Buffalo, New York 14203
DEC 0 7 2001
Re: K013040 Trade/Device Name: Light Saber™ Introducer Needle Regulation Number: 880.5860, 878.4800 Regulation Name: Piston syringe Manual surgical instrument for general use Regulatory Class: II Product Code: FMF, MDM Dated: September 7, 2001 Received: September 10, 2001
Dear Mr. Riggi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as sured in the encreated of the enactment date of the Medical Device Amendments, or to coniments provision to May 20, 1976, the occordance with the provisions of the Federal Food, DINEA devices that have been recuired in assee approval of a premarket approval application (PMA). alla Cosmetic 710-11-184, that 20 hot sequence to the general controls provisions of the Act. The Tou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 IT your device is classified (500 a00 roy ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FR may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may ou found in the Our cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that 1 Dr. 3 issualled of a complies with other requirements of the Act mall I DA has made a determinations administered by other Federal agencies. You must of any i cacal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Hot 601 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. John Riggi
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter with and my your e FDA finding of substantial equivalence of your device to a legally prematics noticated. " The station 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 11 you desire specific arris 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 8659. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 + + the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general 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/dsma/dsmamain.html
Sincerely yours,
R. Mark A. Millison
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 5 - INDICATIONS FOR USE
Indications for Use Form
KO13040 510(k) Number (if known):_
Device Name: Light Saber™ Introducer Needle
Intended Use: A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
Indications for Use: For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K013040
Prescription Use _V (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.