(448 days)
No
The device is described as a manual, reusable surgical instrument with no mention of software, algorithms, or any form of computational processing. The description focuses on the physical characteristics and performance of the instrument itself.
No.
The device is a surgical instrument for cutting bone, not a device used for therapy, diagnosis, or treatment of a disease or condition for therapeutic benefit.
No
Explanation: The device is a surgical instrument (rongeur) used for cutting or biting bone during surgery. It is an operative tool and not designed to diagnose a condition or disease.
No
The device is a manual, reusable, stainless-steel surgical instrument and does not contain any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting or biting bone during surgery involving the skull or spinal column." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a manual, reusable surgical instrument made of stainless steel.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Anatomical Site: The device is used on the skull or spinal column, which are parts of the living patient's anatomy, not in a laboratory setting for diagnostic testing.
The device is a surgical instrument used during a medical procedure, not a tool for diagnosing a condition based on in vitro analysis.
N/A
Intended Use / Indications for Use
KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
HAE
Device Description
The KLS Martin Neuro Rongeurs are manual, reusable, stainless-steel instruments. They are provided non-sterile and must be cleaned and sterilized by the end user before use. Validated methods are provided in the instructions for use that accompany each device. The instruments are available coated or uncoated in a variety of styles, with options for a range of cutting angles, shaft lengths and profiles, jaw widths, and handle designs. Additionally, the KLS Martin Neuro Rongeurs can have a push button opening mechanism to allow separation of the long shafts allowing for improved cleaning and sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine & cranium
Indicated Patient Age Range
two years of age or older.
Intended User / Care Setting
Professional users: The instruments may be used only by surgical specialists. Reprocessing must be performed accordingly by trained and qualified personnel of the reprocessing unit for medical devices.
Sterile OR
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)
Performance Testing - Non-clinical:
- Autoclave Test: Test to verify corrosion resistance during autoclaving. Result: No corrosion detected.
- Boiling Test: Test to verify corrosion resistance of instruments. Result: No corrosion detected.
- Copper Sulfate Test: Test to verify corrosion resistance of instruments. Result: No corrosion detected.
- Thermal Test: Test to verify thermal resistance of instruments. Result: No corrosion detected.
- Cut Quality: Compare cut quality. Result: Smooth cuts achieved, pass.
Comparative Functional Testing:
- Spring Force: Compare spring force. Result: Comparable to reference device.
- Cut Force: Compare cut force. Result: Comparable to reference device.
- Push Button Force: Compare push button force. Result: Comparable to reference device.
Biocompatibility Testing: Biocompatibility endpoints were evaluated in accordance with ISO 10993. Biocompatibility testing for chemical characterization of leachables, cytotoxicity, sensitization, irritation, material mediated pyrogenicity and hemocompatibility. Test results indicate that the KLS Martin Neuro Rongeurs are biocompatible.
Sterilization Testing: Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with AAMI ANSI ISO 17665-1 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. All test method acceptance criteria were met.
Performance Testing - Clinical: Clinical testing was not necessary for the substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
June 3, 2022
KLS-Martin L.P. Susan Leander Regulatory Affairs Project Supervisor 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K210741
Trade/Device Name: KLS Martin Neuro Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: May 2, 2022 Received: May 3, 2022
Dear Susan Leander:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210741
Device Name KLS Martin Neuro Rongeurs
Indications for Use (Describe)
KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary K210741 | |
|---|---|
| Submitter: | KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 |
| Contact Person: | Susan Leander Regulatory Affairs Project Supervisor Phone: 800-625-1557 Email: susan.leander@klsmartinusa.com |
| Alternate Correspondent: | Melissa Bachorski Assistant Director, RA/QMS Phone: 800-625-1557 Email: regaffairs@klsmartin.com |
| Date Prepared: | May 31, 2022 |
| Trade Name: | KLS Martin Neuro Rongeurs |
| Common Name: | Manual Rongeur |
| Classification Name: | Manual Rongeur (21 CFR 882.4840) |
| Regulatory Class: | II |
| Product Code: | HAE |
| Predicate Device: | K-2 Medical GmbH & Co. KG (K150468) Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs |
| Reference Device: | INSTRUMED INTERNATIONAL, INC.(K081651) Instrumed Rongeur |
Device Description
The KLS Martin Neuro Rongeurs are manual, reusable, stainless-steel instruments. They are provided non-sterile and must be cleaned and sterilized by the end user before use. Validated methods are provided in the instructions for use that accompany each device. The instruments are available coated or uncoated in a variety of styles, with options for a range of cutting angles, shaft lengths and profiles, jaw widths, and handle designs. Additionally, the KLS Martin Neuro Rongeurs can have a push button opening mechanism to allow separation of the long shafts allowing for improved cleaning and sterilization.
Indications for Use
The KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age and older.
4
Technological Characteristics & Substantial Equivalence Discussion
The subject device, KLS Martin Neuro Rongeurs, is comparable in materials, design, composition, and function to the predicate device. K150468. The only differences are in some of the options available, such as cutting angles and shaft lengths. The subject device has jaw widths ranging from 1 mm to 6 mm, which is the same as the predicate device. The subject devices have cutting angles that are equivalent to those of the predicate and reference devices. Cutting angles range from 30° to 90° and can angle up or down. The selection of cutting angles allow for greater accessibility to the surgical site. Shaft lengths range from 6 to 15 inches for the predicate device and from 15 to 30 cm (~6 to ~12 inches) for the subject device. Rongeurs are multipurpose instruments that can be used in a variety of applications to cut and bite bone for access to underlying tissue. All of these options are surgeon's preference and do not raise new questions of safety or effectiveness of the instruments.
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| | KLS Martin Neuro Rongeurs
(K210741) | K2 Medical(K150468)
Laminectomy Rongeurs, Kerrison
Rongeurs, IVD Rongeurs | Medline (Instrumed) Rongeurs
(K081651) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate | Reference Device |
| Indications for Use | The KLS Martin Neuro
Rongeurs are manually operated
instruments indicated for cutting
or biting bone during surgery
involving the skull or spinal
column in patients two years of
age or older. | Laminectomy Rongeurs, Kerrison
Rongeurs and IVD Rongeurs are
manually operated instruments indicated
for cutting or biting bone during surgery
involving the skull or spinal column in
patients two years of age or older. | The intended use of Instrumed Rongeur
is to access, cut and bite soft tissue and
bone during surgery involving the spinal
column. |
| Contraindications | No known contraindications | None specified. | None specified. |
| Rx or OTC | Rx | Rx | Rx |
| Single Use or
Reusable | Reusable | Same | Same |
| Opening mechanism | Push button | Same | Same |
| Classification | 21 CFR 882.4840
Class II | 21 CFR 882.4840
Class II | 21 CFR 882.4840
Class II |
| Product Code | HAE | HAE | HAE |
| Material | Stainless steel
1.4021/X20Cr13/AISI 420A
1.4305/X8CrNiS18-9/AISI 303
1.4310 /X10CrNi18-8/AISI 301
TiAlN coating (Solid Black option)
Gold plating | Stainless Steel AISI 420 A
Titanium acc. ASTM F136
/ ISO 5832-3 several
surface coatings:
anthracite, gold, black
silicone coated handle | Not stated. |
| Cleaning | Must be cleaned following a
validated method before each use | Same | Same |
| | KLS Martin Neuro Rongeurs
(K210741) | K2 Medical(K150468)
Laminectomy Rongeurs, Kerrison
Rongeurs, IVDRongeurs | Medline (Instrumed) Rongeurs
(K081651) |
| | Subject Device | Primary Predicate | Reference Device |
| Sterilization | Non-sterile
Must be sterilized following a
validated method before each use | Same | Same |
| Anatomical Sites | Spine & cranium | Same | Spine |
| Use Environment | Sterile OR | Same | Same |
| User | Professional users: The
instruments may be used only
by surgical specialists.
Reprocessing must be performed
accordingly by trained and qualified
personnel of the reprocessing unit
for medical devices. | Same | Same |
6
7
Performance Testing - Non-clinical
Performance Testing
KLS Martin Neuro Rongeurs were evaluated for corrosion and heat resistance. Comparative testing was completed versus the reference device, the Medline (Instrumed) Rongeurs (K081651).
Performance Testing
| Test Name | Test Description | Result |
|---|---|---|
| Autoclave Test | Test to verify corrosion resistance | |
| during autoclaving. | No corrosion detected | |
| Boiling Test | Test to verify corrosion | |
| resistance of instruments. | No corrosion detected | |
| Copper Sulfate Test | Test to verify corrosion | |
| resistance of instruments. | No corrosion detected | |
| Thermal Test | Test to verify thermal | |
| resistance of instruments. | No corrosion detected | |
| Cut Quality | Compare cut quality | Smooth cuts achieved, pass |
Comparative Functional Testing
| Test Name | Test Description | Result |
|---|---|---|
| Spring Force | Compare spring force | Comparable to reference device |
| Cut Force | Compare cut force | Comparable to reference device |
| Push Button Force | Compare push button force | Comparable to reference device |
Biocompatibility Testing
Biocompatibility endpoints were evaluated in accordance with ISO 10993. Biocompatibility testing for chemical characterization of leachables, cytotoxicity, sensitization, irritation, material mediated pyrogenicity and hemocompatibility. Test results indicate that the KLS Martin Neuro Rongeurs are biocompatible.
Sterilization Testing
Steam sterilization validations were performed using the dynamic-air-removal cycle in accordance with AAMI ANSI ISO 17665-1 to a sterility assurance level (SAL) of 10° using the biological indicator (BI) overkill method. All test method acceptance criteria were met.
Performance Testing - Clinical
Clinical testing was not necessary for the substantial equivalence determination.
Substantial Equivalence Conclusion
KLS Martin Neuro Rongeurs are comparable in materials, design, composition, and function to the predicate and reference devices, K150468, K2 Medical Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs and K081651, Medline (Instrumed) Rongeurs. They have the same intended use, same fundamental principles of operation, and same technological features as the predicate device. The KLS Martin Neuro Rongeurs are substantially equivalent to the predicate device.