(90 days)
Not Found
Not Found
No
The summary describes a physical medical device (spinal needle/cannula) and its intended use for fluid injection/retraction. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The reference to a "Dual Radiation Targeting System™" suggests a different type of technology, likely related to imaging or guidance, but not explicitly AI/ML based on this description.
No
The device is a spinal needle/cannula for fluid injection/retraction, intended for use with a targeting system, but it does not directly perform a therapeutic function itself.
No
The device is a needle/cannula for fluid injection or retraction, not for diagnosing medical conditions.
No
The device description clearly describes a physical needle and cannula assembly, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a spinal needle/cannula intended for the injection or retraction of fluids from the body. This is a direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Intended Use: The intended use focuses on delivering or removing fluids during surgical procedures and improving needle placement accuracy. This is a procedural device, not a diagnostic test performed on a sample.
The device is a medical device, but it falls under the category of a surgical or procedural instrument, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Light Saber™ Spinal Needle is a single use disposable spinal needle/cannula intended for the injection of fluid into or aspiration of fluid from the body. This device is indicated for use with MINRAD Inc.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
Product codes (comma separated list FDA assigned to the subject device)
80 FMF, 90 IWE
Device Description
The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
K021084
Page 1 of 2
EXHIBIT A - 510(k) SUMMARY MINRAD, Inc. LIGHT SABER™ SPINAL NEEDLE
| Submitter's Name, Address, Telephone Number, Contact Person
| and Date Prepared | JUL 3 2002 |
|---|---|
| ---------------------------------------------------------------------------------- | ------------ |
MINRAD, INC. 847 Main Street Buffalo, NY 14203
Phone: (716)-855-1068 Facsimile: (716)-855-1071
Kim S. DeVitto Contact Person: Registration Manager
March 28, 2002 Date Prepared:
Name of Device and Name/Address of Sponsor
Light Saber™ Spinal Needle
MINRAD, INC. 847 Main Street Buffalo, NY 14203
Common or Usual Name
Spinal Needle
Classification Name
General and Plastic Surgery Devices
Predicate Devices
-
- Spinal Needle, Ballard Medical Products
-
- Light Saber™ Aspiration Needle, MINRAD, Inc.
Intended Use
The Light Saber™ Spinal Needle is a single use disposable spinal needle/cannula intended for the injection of fluid into or aspiration of fluid from the body. This device is indicated for use with MINRAD Inc.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement.
1
EXHIBIT A - 510(k) SUMMARY MINRAD, Inc. LIGHT SABER™ SPINAL NEEDLE
KO21084
Page 2 of 2
Technological Characteristics
The Light Saber™ Spinal Needle consists of a needle and a collimator to which a stylet is attached. The stylet is enclosed in a cannula/hub assembly with a matching tip. The female Luer of the cannula hub, for the attachment to the syringe, is designed to comply with ISO-594 for "Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Other Medical Equipment." The Light Saber™ Spinal Needles are provided in gauges of 18, 20, 22, 23, and 25. The Light Saber™ Spinal Needle will be provided in lengths of 3.75, 6.25, 8.75, 15 and 20 cm. The tip design for these needles will provide either a Quincke, Short Bevel or Chiba point. Depth markings are standard on the cannula.
Substantial Equivalence
The MINRAD, Inc. Light Saber™ Spinal Needle is substantially equivalent to the predicate devices referenced above. Except for minor differences in general indications for use, size of the needle tip configurations, the MINRAD, Inc. Light Saber™ Spinal Needle is identical to its predicate devices. These minor differences raise no new issues of safety or effectiveness. Thus, the MINRAD, Inc. Light Saber "" Spinal Needle is substantially equivalent to its predicate devices.
0 1
1977
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the eagle in a circular fashion.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 ப்பட
Re: K021084
Trade/Device Name: Light Saber™ Spinal Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: 80 FMF Regulation Number: 21 CFR 892.5780 Regulation Name: Light beam patient position indicator Regulatory Class: I Product Code: 90 IWE Dated: April 2, 2002 Received: April 4, 2002
Dear Ms. DeVitto:
ર્ત્યું હતું.
Ms. Kim S. DeVitto
Minrad. Inc.
847 Main Street
Registration Manager
BUFFALO NY 14203
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), y 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 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); 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EXHIBIT H
INDICATIONS FOR USE
| Indications for Use Form | |
|---|---|
| 510(k) Number (if known): | K021084 |
| Device Name: | Light Saber™ Spinal Needle |
| Intended Use: | A single use disposable spinal needle/cannula intended for the injection of fluids into or retraction of fluids from the body. |
| Indications for Use: | A single use disposable spinal needle/cannula indicated for the injection or retraction of fluids from the body during surgical procedures. This device is indicated for use with MINRAD INC.'s Dual Radiation Targeting System™ (DRTS) to improve the accuracy of needle placement. |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 C.F.R. 801.109) |
Navey C hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K021084 |
|---|---|
| --------------- | --------- |
036