(88 days)
Not Found
Not Found
No
The document describes a physical introducer needle and its components, with no mention of software, algorithms, or AI/ML capabilities. The intended use refers to improving accuracy with a separate system (DRTS), but the device itself is a mechanical needle.
No.
The device is an introducer needle/cannula used for needle placement accuracy in non-vascular procedures, but it does not directly treat a disease or condition.
No
The device is an introducer needle/cannula used for needle placement, not for diagnosing a condition or disease.
No
The device description clearly details physical components like a needle, collimator, cannula/hub assembly, and Luer fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a "single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures." This describes a device used in vivo (within the body) for accessing a site.
- Indications for Use: The indications are for use with a "Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement." This further reinforces its use in a procedural setting on a patient.
- Device Description: The description details a needle, cannula, and hub assembly designed for percutaneous access to the body. It mentions features like depth markings and Luer fittings for connection to syringes, all consistent with a device used for accessing and potentially delivering or aspirating substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device is clearly designed for direct interaction with the patient's body during a procedure.
N/A
Intended Use / Indications for 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.
A single use disposable introducer needle/cannula intended for A single use disposuble wires in non-vascular procedures.
For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
Product codes
FMF, MDM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Introducer Needle Accessory, Oratec Interventions, Inc., Light SaberTM Aspiration Needle, MINRAD, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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.
3
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
4
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)