(75 days)
The DISTALOCK™ Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
The DISTALOCK™ Femoral Intramedullary (IM) Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The DISTALOCK™ Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The DISTALOCK™ Femoral IM Nail System includes the following components: DISTALOCK™ IM standard entry and trochanteric nails, locking screws and end caps made of titanium allov. The DISTALOCK™ Ancillary Instrumentation includes the DISTALOCK™ drill, the DISTALOCK™ Control System (which includes the control box, drill motor assembly and hand controller) and other disposable and reusable instruments.
The provided document is a 510(k) summary for the DISTALOCK™ Femoral Intramedullary Nail System, which is a medical device. This type of document is relevant for demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving a device meets those criteria in the way a diagnostic AI/ML device submission would.
Therefore, many of the requested categories (such as sample size, ground truth, expert qualifications, MRMC studies, standalone performance, and training set information) are not applicable to this type of device and submission.
However, I can extract the information that is present:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Acceptance Criteria Category | Description | Reported Device Performance | Study Type |
|---|---|---|---|
| Biocompatibility | Selection of materials demonstrating appropriate levels of biocompatibility. | Achieved through selection of appropriate materials. | Biological Safety testing |
| Human Factors | Acceptable human factors features in device functioning and labeling. | Concluded as acceptable. | Human Factor Analysis |
| Performance & Safety | Device performs as intended, is safe, and is substantially equivalent to predicate device. | Bench testing and cadaver testing demonstrated performance and safety, confirming substantial equivalence. | Bench Testing, Cadaver Testing |
| Risk Assessment | No new risks or efficacy concerns compared to the predicate device. | Confirmed no new questions of safety or effectiveness. | Risk Assessment |
| Design Verification & Validation | Device system as modified is as safe as the predicate device. | Results demonstrate the modified device is as safe as the predicate. | Design Verification & Validation Testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device (intramedullary nail), and the "test set" would refer to physical devices or cadavers, not a data set in the AI/ML sense. The document does not specify sample sizes for bench or cadaver testing. Data provenance such as country of origin or retrospective/prospective is not relevant in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" using human experts in the context of diagnostic performance is described for this physical device. The testing involved engineering, material science, and possibly anatomical cadaver studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations of data, such as images, which is not the primary focus of this device's testing.
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
Not applicable. This is not an AI/ML diagnostic device, so MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be defined by engineering specifications, material science standards, and established biomechanical principles for orthopedic fixation. For cadaver testing, the "ground truth" would be the successful mechanical fixation of fractures as assessed by engineers or orthopedic experts in a controlled setting, potentially comparing against the predicate device's performance. The document doesn't explicitly detail the "type" of ground truth but implies it's based on engineering and biomechanical performance.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this physical device.
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K100312(1/2)
10(k) Summa er 21 CFR 807.87
APR 2 0 2010
| Common/Usual Name: | Intramedullary Fixation Rod and Accessories |
|---|---|
| Product Trade Name: | DISTALOCK™ Femoral Intramedullary Nail System |
| Classification Name: | Rod, Fixation, Intramedullary and AccessoriesClass II per 21 CFR § 888.3020Product Code HSB |
| Predicate Device: | DGIMED Ortho Inc. Revolution™ Femoral IntramedullaryNail System K091309 |
| Manufacturer: | DGIMED Ortho, Inc.12400 Whitewater Drive, Suite 2010Minnetonka, MN 55343 |
| Contact: | Scott YoungstromVP of Finance, Chief Operating Officer |
| Date Prepared: | February 3, 2010 |
Device Description:
The DISTALOCK™ Femoral Intramedullary (IM) Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The DISTALOCK™ Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The DISTALOCK™ Femoral IM Nail System includes the following components: DISTALOCK™ IM standard entry and trochanteric nails, locking screws and end caps made of titanium allov. The DISTALOCK™ Ancillary Instrumentation includes the DISTALOCK™ drill, the DISTALOCK™ Control System (which includes the control box, drill motor assembly and hand controller) and other disposable and reusable instruments.
Indications for Use:
The DISTALOCK™ Femoral IM Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
Page 1
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Substantial Equivalence Comparison:
Results of design verification and validation testing demonstrate that the device system as modified is as safe as the predicate device. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the DISTALOCK™ Femoral IM Nail System, as modified, raises no new questions of safety or effectiveness compared to the predicate device. The DISTALOCK™ Femoral IM Nail System has been shown to be substantially equivalent to the legally marketed device for the purpose of 510(k) clearance.
Summary of Non-Clinical Testing:
The biological safety of the DISTALOCK™ Femoral IM Nail System was achieved through the selection of materials that demonstrated appropriate levels of biocompatibility. Human factor analysis was conducted and concluded that the DISTALOCK™ Femoral IM Nail System presented acceptable human factors features in both the functioning of the device and usage of the labeling. Bench testing and cadaver testing were conducted to ensure the performance and safety of the DISTALOCK™ Femoral IM Nail System and to demonstrate substantial equivalent to predicate device.
No new risks or efficacy concerns other than those identified with the predicate device were raised. Results of non-clinical testing demonstrated that the DISTALOCK ™ Femoral Intramedullary (IM) Nail System is safe and effective for its intended use.
Conclusion:
The DISTALOCK™ Femoral IM Nail System has similar intended use, material biosafety profile, and technical characteristics as the predicate device. Non-clinical testing was conducted to verify the safety and performance of the DISTALOCK™ Femoral IM Nail System and to ensure the device functions as intended and meets design specifications. As a result, the DISTALOCK™ Femoral IM Nail System has been demonstrated to be substantially equivalent to the predicate device and effective for its intended use.
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Image /page/2/Picture/0 description: The image shows a partial view of a logo or emblem, featuring a stylized bird-like symbol on the left. To the right of the symbol, the word "DEPART" is visible, suggesting that the full text may be "DEPARTMENT". The overall design appears to be official, possibly representing a government or organizational entity.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DGIMED Ortho, Inc. % Mr. Scott Youngstrom Vice President of Finance, Chief Operating Officer 12400 Whitewater Drive, Suite 2010 Minnetonka, Minnesota 55343
APR 2 0 2010
Re: K100312
Trade/Device Name: DISTALOCK™ Femoral Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: March 30, 2010 Received: April 1, 2010
Dear Mr. Youngstrom:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Scott Youngstrom
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Darbar Buchm
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Current 510(k) Number: _ | | 003 | 2
Device Name:
DISTALOCK™ Femoral Intramedullary Nail System
Indications for Use:
The DISTALOCK™ Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.
Prescription Use ✓ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Onette for mxr
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100312
N/A