(20 days)
Shoulder - rotator cuff repair
Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
The provided text describes a 510(k) summary for the Li Medical RotorBlade™ suture anchor and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through extensive clinical trials with specific acceptance criteria in the way a pharmaceutical or novel medical device might.
Therefore, the information requested for a detailed study description and acceptance criteria is not fully available or applicable in the context of this 510(k) submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal acceptance criteria in a quantitative table. The primary "criterion" for this 510(k) was to demonstrate substantial equivalence to the predicate device (Li Medical RotorBlade™ K983435 & K992938).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Identical to predicate device. | The LM Anchor is identical to the predicate device in its intended use, and similar in safety and effectiveness. Intended use: Shoulder - rotator cuff repair. |
| Safety and Effectiveness: Similar to predicate device. | The LM Anchor is identical to the predicate device in its intended use, and similar in safety and effectiveness. |
| Pullout Strength: Substantially equivalent to predicate device. | Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the predicate device. (No specific numerical values or acceptance ranges are provided for either the new or predicate device's pullout strength.) |
| Material: Same as predicate device. | Made from surgical grade PLL (homopolymer poly (L(-)-lactide). (Implied to be the same as the predicate, as the only described difference is sterilization method). |
| Design: Same as predicate device. | Designed as a propeller blade type anchor device. (Implied to be the same as the predicate, as the only described difference is sterilization method). |
| Sterilization: Acceptable method. | The only difference between the new anchor and the predicate device is that the gamma radiation has been added as a potential sterilization method. (This change was deemed acceptable by the FDA). |
2. Sample Size Used for the Test Set and Data Provenance:
- The text mentions "Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent..."
- Sample Size: Not specified.
- Data Provenance: Not specified, but "pre-clinical testing" typically refers to in vitro or ex vivo studies, not human clinical data. Given the device type, it's highly likely this was mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This type of information (experts establishing ground truth) is not applicable to the pre-clinical mechanical testing described for this device. Ground truth for pullout strength would be objective measurements from testing equipment, not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or experts, which is not relevant to mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is designed to assess the diagnostic performance of a device with human readers, often for image interpretation. This device is a surgical implant, and the testing described is mechanical, not diagnostic.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical anchor, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI is not relevant.
7. The Type of Ground Truth Used:
- For the "pre-clinical testing" mentioned (specifically pullout strength), the ground truth would be objective engineering measurements (e.g., force in Newtons or pounds-force) obtained directly from a testing machine (e.g., a universal testing machine).
8. The Sample Size for the Training Set:
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device underwent pre-clinical mechanical testing, not algorithm development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set for an algorithm was used.
In summary: This 510(k) submission relies on demonstrating substantial equivalence primarily through pre-clinical mechanical testing (specifically pullout strength) and by showing identical design, material, and intended use as a previously cleared predicate device, with only the sterilization method changing. The regulatory pathway of 510(k) premarket notification does not typically require the extensive clinical trials or expert consensus-based studies associated with establishing acceptance criteria and ground truth in the way described in your template.
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0CT 2 7 1999
:
K993373
510(K) SUMMARY
| Device Sponsor: | Li Medical, 4 Armstrong Road, Shelton, CT 06484, |
|---|---|
| Contact:Date: | Rhodemann Li, Vice PresidentSeptember 30, 1999 |
| Classification Name:Common Name:Proprietary Name: | UnclassifiedBone anchorLi Medical RotorBladeTM |
| Predicate Device: | Li Medical RotorBladeTM (K983435 & K992938) |
| Device Description: | Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller bladetype anchor device through which suture is passed toprovide a means for soft tissue to bone attachment. |
| Intended Use: | Shoulder - rotator cuff repair |
| Technical Comparison: | The LM Anchor is identical to the predicate devicein itsintended use, and similar in safety and effectiveness. Theonly difference between the new anchor and the predicatedevice is that the gamma radiation has been added as apotential sterilization method. |
| Performance Data: | Pre-clinical testing showed that the mean pullout strengthof the LM Anchor was substantially equivalent to the meanpullout strength of the predicate device. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Mr. Rhodemann Li Vice President Li Medical Technologies, Inc. 4 Armstrong Road Shelton, Connecticut 06484
Re: K993373 RotorBlade™ Suture Anchor Trade Name: Regulatory Class: II Product Codes: MAI and GAS Dated: September 30, 1999 Received: October 7, 1999
Dear Mr. Li:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent. (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Rhodemann Li
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name:
LM Anchor
Indications For Use: Shoulder: rotator cuff repair
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Piolles B
(Division Sign-Off) Division of General Restorative I 510(k) Numbe
Prescription Use (Pcr 21 CFR 801.109)
OR
.
Over-The-Counter Use__________ (Optional Format 1-2-96)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.