(57 days)
The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.
The Laurimed 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 (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device
The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
Here's an analysis of the provided text regarding the acceptance criteria and study information:
Based on the provided 510(k) summary, there is no specific acceptance criteria or study that proves device performance in a clinical or standalone setting using human data. The submission relies solely on a comparison to a predicate device and non-clinical (i.e., bench or lab) testing.
Here's a breakdown of why and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated within the provided text. The submission focuses on substantial equivalence to a predicate device. | "Results of non-clinical testing demonstrated that the Laurimed Dissectorny System is safe and effective for its intended use." (From section "Summary of Non-Clinical Data I.") |
| Implied criteria: Substantial equivalence to the predicate device (Laurimed Percutaneous Discectomy System, K082194) in terms of intended use and technological characteristics. | "The Laurimed Discectomy System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. ... The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device and is safe and effective for its intended use." (From section "Summary of Data J.") |
| Implied criteria: Functions as intended and meets design specifications. | "...non-clinical testing was conducted to validate the performance of the device and ensure the Laurimed Discectomy System functions as intended and meets design specifications." (From section "Summary of Data J.") |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The summary explicitly states "Summary of Non-Clinical Data." This indicates that no human test set data was used or presented in this 510(k) summary. The testing was likely limited to bench or laboratory evaluations to demonstrate functionality and safety characteristics (e.g., cutting efficacy, aspiration flow, material compatibility, sterilization effectiveness).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since there's no clinical test set with human data, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. As no human test set was used, no adjudication method 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:
- No. This device is a surgical tool (discectomy system) and does not involve AI or human readers for image interpretation. Therefore, an MRMC study or AI-assisted performance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical surgical tool, not an algorithm. Standalone performance as typically understood for AI/software devices is not applicable. The "standalone" performance here would refer to the device's mechanical and functional performance, which was assessed through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For the non-clinical testing mentioned, the "ground truth" would likely be defined by engineering specifications, material properties, and established test methodologies (e.g., force measurements, flow rates, visual inspection of cut tissue substitutes). No clinical or expert-based ground truth is discussed.
8. The sample size for the training set:
- Not applicable / Not provided. This is a hardware medical device, not an AI or software algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set data is relevant to this device.
In summary, this 510(k) submission for the Laurimed Discectomy System primarily relies on:
- Substantial Equivalence: A direct comparison to a legally marketed predicate device (Laurimed Percutaneous Discectomy System, K082194) regarding intended use and technological characteristics.
- Non-Clinical (Bench) Testing: To validate the device's performance, ensure it functions as intended, and meets design specifications. This testing covers aspects like safety and effectiveness without involving human subjects.
The absence of clinical study data, expert adjudication, or AI-related metrics is typical for many Class II medical devices cleared via the 510(k) pathway, especially those that are similar in design and function to existing predicate devices and do not introduce novel technology requiring extensive new clinical evidence.
{0}------------------------------------------------
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.
Name, Address, Phone and Fax Number of Applicant A.
Laurimed LLC 500 Arquello Street, Suite 100 Redwood City, CA 94063 Phone: (650) 587-5296 Fax: (650) 587-3823
MAY 21 2009
B. Contact Person
Sevrina Ciucci Regulatory Affairs Consultant (408) 316-4837
C. Date Prepared March 20, 2009
D. Device Name
Laurimed Discectomy System Trade Name: Tissue Cutter/Aspirator Common Name: Arthroscope (21 CFR §8888 1100) Product Code {{ Classification Name:
Predicate Devices E.
The Laurimed Discectomy System is substantially equivalent to the Laurimed Percutaneous Discectomy System (K082194).
Device Description F.
The Laurimed 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 (Dilator, Straight Cannula, Curved Cannula (qty. 2) and Trocar), a Device Cleaner, and a Discectomy Device
The Laurimed Discectomy System is supplied as a sterile, single patient use, single-level, disposable device.
{1}------------------------------------------------
Intended Use G.
The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.
Technological Comparison H.
The technological characteristics and principals of operation of the Laurimed Discectomy System are substantially equivalent to the noted predicate device.
Summary of Non-Clinical Data 1.
Results of non-clinical testing demonstrated that the Laurimed Discectorny System is safe and effective for its intended use.
Summary of Data J.
The Laurimed Discectomy System has been carefully compared to a legally marketed device 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 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 device 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 & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
MAY 2 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Laurimed, LLC % Ms. Sevrina Ciucci Regulatory Affairs Consultant 500 Arguello Street, Suite 100 Redwood City, California 94063
Re: K090815
Trade/Device Name: Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 20, 2009 Received: March 25, 2009
Dear Ms. Ciucci:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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
{3}------------------------------------------------
Page 2 - Ms. Sevrina Ciucci
(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
For D.J., D.J. D.R.
Mark N. Melkerson (Deire D.m.s,i2)
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Laurimed LLC
510(k) Notification Discectomy System
Indication for Use Statement
510(k) Number (if known): K_ O
Device Name: Discectomy System
Indications for Use:
The Laurimed Discectomy System is indicated for use in aspiration of disc material during open discectomies in the lumbar region of the spine.
Prescription Use
OR
Over-The-Counter Use
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neleela forman
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090815
Appendix I, Page 1 of 1
§ 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.