(168 days)
The OsteoMed Neuro Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.
The OsteoMed Neuro Rongeur is a low profile instrument designed to cut bone 180° off the straight axis of the ronguer. It has a rectangular scoopshaped tip which compresses and cuts cranial or spinal bone. The ronguer is a manually operated instrument used for cutting and biting soft tissue and bone during surgery involving the skull or spinal column. The OsteoMed Neuro Rongeur is made from Medical Grade Stainless Steel per ASTM F-899.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to make effective cuts in media | Both the OsteoMed Neuro Rongeur and the Instrumed Micro Kerrison Rongeur made effective cuts in the same media. |
| Equivalent force comparison during cutting | The data demonstrated that both instruments performed equally in terms of force required to make cuts. |
| Equivalent overall cutting mechanics | The change in design (180° off-axis cut versus 90° for predicates) does not affect the overall cutting mechanics of the device. |
| Biocompatibility of materials | The OsteoMed Neuro Rongeur is made from medical grade stainless steel, which is biocompatible, similar to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of a typical AI/software study. Instead, the performance evaluation was a direct comparison between the OsteoMed Neuro Rongeur and a predicate device (Instrumed Micro Kerrison Rongeur) using "the same media."
- Sample size: Not explicitly stated as a number of "samples" or "cases." The testing involved a comparison of "force comparison" while "making cuts" in "the same media." This implies a series of cuts or measurements were taken, but the quantity of these measurements is not provided.
- Data provenance: Not specified. It's likely an in-house laboratory study.
- Retrospective/Prospective: Prospective, as it was a direct comparison experiment.
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. This is not a study requiring expert-established ground truth for a test set. The performance assessment was based on objective mechanical measurements (force comparison and effective cuts) rather than subjective expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was used as there was no expert-derived ground truth.
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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manually operated surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to objective mechanical performance:
- Ability to make effective cuts: Visually assessing if the rongeur successfully cut the media.
- Force comparison: Quantifiable measurement of force required to make cuts.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There was no training set for this device.
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DEC - 6 2013
510(k) Summary
Submitter Information:
OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Mrs. Piedad Peña, MS
Date Prepared:
October 26, 2013
Device Information:
Proprietary/Trade Name: OsteoMed Neuro Rongeur Common Name: Manual Rongeur
OsteoMed Neuro Rongeur
Manual Rongeur
Classification Name:
o Regulation Number: 21 CFR 882.4840
- o Regulation Name: Manual Rongeur
- o Product Code: HAE
Device Class: II
Predicate Devices:
Instrumed Micro Kerrison Rongeur (K081651)
Common Name: Manual Rongeur
Classification Name:
- o Regulation Number: 21 CFR 882.4840
- o Regulation Name: Manual Rongeur
- o Product Code: HAE
Device Class: II
Integra Kerrison Rongeur (K09227)
Common Name: Manual Rongeur
Classification Name:
- o Requiation Number: 21 CFR 882.4840
- o Regulation Name: Manual Rongeur
- o Product Code: HAE
Device Class: II
Device Description:
The OsteoMed Neuro Rongeur is a low profile instrument designed to cut bone 180° off the straight axis of the ronguer. It has a rectangular scoopshaped tip which compresses and cuts cranial or spinal bone. The ronguer is a manually operated instrument used for cutting and biting soft tissue and bone during surgery involving the skull or spinal column.
The OsteoMed Neuro Rongeur is made from Medical Grade Stainless Steel per ASTM F-899.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (989) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
COLSON ASSOCIATI
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Indications for Use/Intended Use:
The OsteoMed Neuro Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.
Target Population:
Adults and Pediatric population
Technological Characteristics:
The OsteoMed Neuro Rongeur, the Instrumed Micro Kerrison Rongeur (K081651) and the Integra Kerrison Rongeur (K092227) are predicate devices used for cutting bone and soft tissue during surgery of the skull and the spinal column. The predicates have a scoop-shaped cutting tip which also compress and cut bone. The difference between the predicate devices and the OsteoMed Neuro Rongeur is the cut. The cut is made at 180 degrees off the straight axis, as oppose to 90 degrees off the straight axis for the predicates. The change in the design does not affect the change in the overall cutting mechanics of the device.
Material used for the OsteoMed Neuro Rongeur and the predicates is medical grade stainless steel. The material used for the OsteoMed Neuro Rongeur and the predicates is biocompatible.
Performance / Clinical Data:
The OsteoMed Neuro Rongeur was compared to the Instrumed Micro Kerrison Rongeur (K081651) and the Integra Kerrison Rongeur (K092227). The testing consisted of force companson of the Instrumed Micro Kerrison Rongeur (K081651), while making cuts in the same media. The data demonstrated that both instruments made effective cuts and performed equally. Therefore the OsteoMed Rongeur performed as well as the Instrumed Micro Kerrison Rongeur.
The indications for use of the OsteoMed Neuro Rongeur and the Integra Kerrison Rongeur are identical indications for both skull and spinal column bone cutting. The indications for use of the Instrumed Micro Kerrison Rongeur are also identical with the exception where cutting the skull is not included.
Clinical Testing is not required to support substantial equivalence.
In conclusion, the device is safe and effective and performs as well as the Instrumed Micro Kerrison Rongeur (K081651) and the Integra Kerrison Rongeur (K092227).
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Substantial Equivalence:
Substantial equivalence for this device is based on similarities in intended use, function (design and technology), performance, and operational principle to the predicate devices, Integra Kerrison Rongeur (K092227) and Instrumed Micro Kerrison Rongeur (K081651) based on their promotional materials, labeling and clearance letter.
- The OsteoMed Neuro Rongeur intended use and indications for use is . exactly like the Integra Kerrison Rongeur (K092227) for cranial and spine applications; Neuro Surgery.
- The material used for the OsteoMed Neuro Ronguer as is the same material . used for both the Instrumed and Integra Rongeurs predicate rongeurs; stainless steel.
- The design, operational principle and technology of cutting the bone is similar . to both the Instrumed and Integra predicate rongeurs. The material is captured and removed the same as the predicate devices. The down mechanical cut of the OsteoMed Neuro Ronguer is similar to the predicates, which have both down or up cuts as well. Therefore the differences in the direction of the mechanical cut do not add any safety or efficacy issues.
Due to the similarity of intended use, indications for use, function, materials, performance, and operational principle to the predicate devices, OsteoMed believes that the OsteoMed Neuro Rongeur does not raise any new safety or effectiveness issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
OsteoMed c/o Mrs. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, TX 75001
Re: K131851
Trade/Device Name: OsteoMed Neuro Rongeur Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: November 5, 2013 Received: November 6, 2013
Dear Mrs. Peña:
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
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Page 2 - Mrs. Piedad Peña
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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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -A
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131851
Device Name: OsteoMed Neuro Rongeur
Indications For Use:
The OsteoMed Neuro Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Victor Krauthamer -A 2013.12.06 16:41:36 -05'00'
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§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).