(106 days)
No
The device description focuses on mechanical components and a laser-based targeting system, with no mention of AI or ML.
No
The device is used for obtaining biopsies and as a port for guidewires, which are diagnostic and procedural functions, not therapeutic.
No
The device is used to obtain biopsies and place guidewires, which are procedural and access functions, not diagnostic capabilities. While a biopsy can lead to a diagnosis, the device itself is for obtaining the sample, not diagnosing.
No
The device description clearly outlines physical components made of stainless steel and plastic, including a stylet, cannula, and handle. It is a physical medical device used for biopsies and guidewire placement.
Based on the provided information, the Light Sabre™ Spinal Access Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain biopsies of bone and/or bone marrow and to provide a port of entry for guidewires during percutaneous spinal procedures. These are direct surgical/interventional procedures performed on the patient's body.
- Device Description: The device is a physical instrument (needle/cannula) used for accessing tissue within the body. It also incorporates a targeting mechanism that interacts with an external laser system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The Light Sabre™ Spinal Access Device is used on the patient's body to obtain the specimen or facilitate a procedure.
The device is a surgical/interventional tool, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, bone, bone marrow
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)
All materials used in the fabrication of the Light Sabre™ Spinal Access Device will be evaluated through biological qualification safety tests as outlined in the applicable sections of ISO 10993. These materials will also be tested in accordance with industry recognized test methods that are applicable based on the intended use of the device.
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.
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.
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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.
0
PREMARKET NOTIFICATION 510(k)
Ko71814
| 5.0 | 510(k) Summary or 510(k) Statement | OCT 16 2007 | |
|---|---|---|---|
| MINRAD | |||
| 510(k) Summary | |||
| 1. | 510(k) owner's name: | Minrad, Inc. | |
| 2. | Address: | 50 Cobham Drive | |
| Orchard Park, NY 14127 | |||
| Phone: (716) 855-1068 | |||
| Facsimile: (716) 855-1078 | |||
| Contact: | John McNeirney, | ||
| Senior Vice President & Chief Technical Officer | |||
| 3. | Preparation Date: | June 29, 2007 | |
| 4. | Device name: | Light Sabre™ Spinal Access Device | |
| 5. | Common name: | Biopsy Needle | |
| 6. | Product classification: | Instrument, Biopsy (21 CFR 876.1075, Product Code KNW) | |
| 7. | Predicate device: | Light Sabre™ Bone Biopsy Needle (K982735) | |
| 8. | Description of device: | The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market | |
| Minrad, Inc. | |||
| 50 Cobham Drive | 12 of 45 |
50 Cobham Drive Orchard Park, NY 14127
CONFIDENTIAL
1
PREMARKET NOTIFICATION 510(k)
| | under K022935. To do this, the Light Sabre™ Spinal
Access Device incorporates a collimating channel and
light-dispersing element directly into the stylet assembly.
When the Light Sabre™ Spinal Access Device is aligned
with the laser beam of the SabreSource™ Targeting
System, the laser will clearly illuminate the light-
dispersing element. Whenever the device is moved out of
the path, as defined by the laser beam, the light-
dispersing element of the Light Sabre™ Spinal Access
Device ceases to glow. | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9.
Voluntary
standards: | There are not any specific standards promulgated but the
Light Sabre™ Spinal Access Device will be
manufactured in accordance with following standards:
- ASTM F1140-00
- ANSI/AAMI/ISO 11137:1994
- ANSI/AAMI/ISO 11737-1:1995
- AAMI TIR 17:1997
- AAMI TIR 27:2001
- ANSI/AAMI/ISO TIR 15843:2000
- ANSI/AAMI ST 72:2002
- ASTM D-5276-98(2004)
- ASTM F88-06
- ISO 11607
- ISO 9626:1991
- ISO 594:1986
- ISO 10993-1:2003
- ISO 10993-5:1999
- ISO 10993-10:2002 | |
| 10. Intended use and
indication for use: | The Light Sabre™ Spinal Access Device is a single-use
disposable device that is used to obtain biopsies of bone
and/or bone marrow and is used to provide a port of entry
to place guidewires during percutaneous spinal
procedures. | |
| 11.
Technological
characteristics: | Indications for Use: A single-use disposable device that
is used to obtain biopsies of bone and/or bone marrow
and is used to provide a port of entry to place guidewires
during percutaneous spinal procedures.
Sterility: Provided sterile for single use
Needle Type: Cannula - Stainless Steel with Plastic Hub
Assembly; Stylet - Stainless Steel with Plastic Hub
Assembly | |
| Needle Length: 10 - 15cm | | |
| Needle Gauge/Diameter: 8, 11, 13 Gauge | | |
| Stainless Steel Material: Stainless Steel 304 | | |
| Stylet/Cannula Hub Material: Gamma Stable | | |
| Polycarbonate | | |
| Method of Sterilization: Gamma Radiation | | |
| Includes method to remove biopsy sample: Included | | |
| in Packaging is Core Sampler made of Stainless Steel | | |
| 304 | | |
| Able to connect Syringe for Aspiration or Injection: | | |
| Luer Lock per ISO 594-2:1998 (E) on Luer Adapter | | |
| Component | | |
| 12. | Testing | All materials used in the fabrication of the Light Sabre™
Spinal Access Device will be evaluated through
biological qualification safety tests as outlined in the
applicable sections of ISO 10993. These materials will
also be tested in accordance with industry recognized test
methods that are applicable based on the intended use of
the device. |
50 Cobham Drive Orchard Park, NY 14127 of 45
CONFIDENTIAL
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2
PREMARKET NOTIFICATION 510(k)
This concludes the 510(k) summary.
.
Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127
.
. .
CONFIDENTIAL
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
OCT 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Minrad, Inc. % Mr. John McNeirney Senior VP and Chief Technical Officer 50 Cobham Drive Orchard Park, New York 14127
Re: K071814
Trade/Device Name: Light Sabre™ Spinal Access Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: August 30, 2007 Received: September 7, 2007
Dear Mr. McNeirney:
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), 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 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.
4
This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PREMARKET NOTIFICATION 510(k)
Indications for Use Statement 4.0
510(k) Number (if known):
Device Name: Light Sabre™ Spinal Access Device
Indications for Use:
The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Division of General, Restorative, nd Neurological Devices
Number 1671814
Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127 11 of 45
CONFIDENTIAL
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