(24 days)
Not Found
No
The summary describes a mechanical device for cutting and aspirating tissue and contains no mention of AI, ML, or related concepts.
Yes
The device is used to aspirate disc material during percutaneous discectomies to treat conditions in the lumbar region of the spine, which aligns with the definition of a therapeutic device.
No
The device is described as cutting and aspirating disc material during percutaneous discectomies, which is an interventional/therapeutic procedure, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (introduction tools, device cleaner, discectomy device) and describes a physical procedure (cutting and aspirating disc material).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration of disc material during percutaneous discectomies in the lumbar region of the spine." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device description details tools used for cutting and aspirating tissue from the spine. This is a physical intervention, not a test performed on a sample outside the body.
- Anatomical Site: The anatomical site is the "lumbar region of the spine," which is a part of the human body.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used within the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
Product codes
HRX
Device Description
The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device.
The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar region of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Results of non-clinical testing demonstrated that the Laurimed Percutaneous Discectomy System is safe and effective for its intended use.
The Laurimed Percutaneous Discectomy System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Laurimed Percutaneous Discectomy System functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate devices and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
0
K082194 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Name, Address, Phone and Fax Number of Applicant
Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: (650) 587-5296 Fax: (650) 587-3823
B. Contact Person
Nancy Lincé Clinical and Regulatory Affairs Consultant (650) 759-6186
C. Date Prepared
August 1, 2008
D. Device Name
Trade Name: Laurimed Percutaneous Discectomy System Common Name: Tissue Cutter/Aspirator Classification Name: Arthroscope (21 CFR §888.1100, Product Code HRX)
E. Predicate Devices
The Laurimed Percutaneous Discectomy System is substantially equivalent to Surgical Dynamics, Inc. Nucleotome 3.5mm Automated Percutaneous Lumbar Discectorny Kit (K923525) and Nucleotome II (Version 2) Tissue Aspirator/Cutter (K914282).
r. Device Description
The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nucleus material from discs in the spine. The system consists of a set of introduction tools (Introducer Needle with Stylet, Guidewire, Dilator, Cannula, Trocar, and Cannula Clamp), a Device Cleaner, and a Discectomy Device
The Laurimed Percutaneous Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
Appendix K, Page 1 of 2
1
G. Intended Use
The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
H. Technological Comparison
The technological characteristics and principals of operation of the Laurimed Percutaneous Discectomy System are substantially equivalent to the noted predicate devices.
l. Summary of Non-Clinical Data
Results of non-clinical testing demonstrated that the Laurimed Percutaneous Discectomy System is safe and effective for its intended use.
J. Summary of Data
The Laurimed Percutaneous Discectomy System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Laurimed Percutaneous Discectomy System functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate devices and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
AUG 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laurimed LLC % Ms. Nancy Lincé Clinical and Regulatory Affairs Consultant 500 Arguello Street, Suite 100 Redwood City, California 94063
Re: K082194
Trade/Device Name: Percutaneous Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 1, 2008 Received: August 4, 2008
Dear Ms. Lincé:
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.
3
Page 2 - Ms. Nancy Lincé
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device advervents. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K 082194
Device Name: Percutaneous Discectomy System
Indications for Use:
The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.
Prescription Use ×
OR (per 21 CFR 801.109) Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Appendix J, Page 1 of 1
.: