(371 days)
Not Found
No
The device description and performance studies focus on the mechanical function, reprocessing, and material properties of manually operated surgical instruments. There is no mention of AI or ML in the text.
No.
The device is a surgical instrument used to cut or bite bone during procedures, which is an interventional function, not a therapeutic one.
No
This device is a surgical instrument used for cutting or biting bone, not for diagnosing medical conditions. The "IVD" in the name refers to "Intervertebral Disk," not "In Vitro Diagnostic."
No
The device description clearly states that the devices are "reusable manual stainless steel instruments" and describes various physical features and materials. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "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 surgical instruments (rongeurs) used for mechanical action (cutting/biting bone).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, or software for analyzing biological samples.
The device is a surgical instrument used during a procedure, not a tool for diagnosing a condition based on in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
Laminectomy Rongeurs, Kerrison Rongeurs, 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.
Product codes (comma separated list FDA assigned to the subject device)
HAE
Device Description
K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
The devices are available with the following features:
Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate
- with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
- with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
- different shaft overall length (6 " inch to 15 " inch) -
- different sizes (1mm to 6 mm)
- different angles (up 40°, up 90°, down 90° -
- without ejector or with different types of ejectors
- with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
- traditional style or with special cleaning channel
- traditional style or with opening mechanism (convertible, take-apart)
- with rotating shaft angled 90° and 40°
IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart
- in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
- with different length and jaw sizes
- angled and straight
- with closed jaw and with fenestrated jaws
- with smooth jaw and with teeth
Laminectomy Rongeurs with double action joints and strong handle
- Fulton Laminectomy Rongeurs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull or spinal column
Indicated Patient Age Range
two years of age or older
Intended User / Care Setting
Not Found
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 data:
- Automatic Reprocessing Validation "Panther Kerrison Rongeur" + Amendment to Automatic Reprocessing Validation "Panther Kerrisson Rongeur.": The test was performed to verify that the devices could be cleaned with the provided cleaning steps in the IFU. This test method is performed by contamination of accessible, interior, and exterior surfaces of instruments intending to reach the sites identified as the least accessible or most difficult to reach sites (worst case). According AAMI TIR 30, the effectiveness of the reprocessing cycle is evaluated by comparing visible contamination (red blood cells), residual protein, the number of organisms and TOC level recovered from the control instruments and the test instruments. This validation provides evidence that viable microbiological contamination as well as a soil contamination of the "Panther Kerrison Rongeur" are removed by the given cleaning and disinfection instructions.
- Sterilization testing: The test is to verify that the devices could be sterilized with the provided sterilization procedure described in the IFU. The test specimens were contaminated with bioindicators or with a challenge suspension and were tested for sterility after the sterilization process. To assure a SAL of 10^-6 only a part cycle of the recommended sterilization process was performed in validation. A reduction of test bacteria was observed and assured showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization.
- Boiling Test: This test is to verify the corrosion resistance of the instruments. It is performed according ASTM F1089-10 section 6.1. Devices are boiled in distilled water for 30 min, cooled down in the water for 3 h and dried at air for 2 h. Devices were not allowed to show signs of corrosion. The tested instruments did not show any signs of corrosion.
- Cytotoxic testing: Test is to show, that no toxic residuals from manufacturing remained on the device. The test was performed with finished devices from all the different materials and coatings according ISO 10993-5. Devices must be considered non cytotoxic. All the tested samples were considered to be NON CYTOTOXIC.
- Irritation testing: The objective of this study was to determine if device-extracts produced an irritation reaction when injected intracutaneously in rabbits. Test was performed according ISO 10993-10 with finished devices in all material-coating configurations. Devices were extracted in 0.9 % saline and cottonseed Oil for 72 h. Extracts were injected intracutaneously and site was graded for tissue reaction at 24, 48 and 72 hours after dose administration. Skin irritation was evaluated according ISO 10993-10. Test data indicated that the device extracts did not cause a skin irritation reaction.
- Mechanical testing - handle force - bite force - extended use: Mechanical tests were performed to compare functional requirements of the K2 Rongeurs with the predicate devices. Therefore the handle force for actuating the device was measured as well as the force to cut artificial bone material. Further on the cutting force and cutting size of new instruments was measured and compared to worn out instruments with the artificial bone material. Devices has to perform similar or better than predicate devices. Test showed that the measured functional specifications of the K2 Rongeurs were equivalent or better than the comparable specifications of the predicate devices.
The nonclinical testing demonstrated, that the K2 Rongeur is substantial equivalent to the predicate device and performs as well as or better than the legally marketed predicate devices.
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human face in profile, composed of three overlapping silhouettes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
March 24, 2016
K2 Medical GmbH & Co. KG Mr. Harald Jung Manager Quality & Regulatory Unter Buchsteig 5 Tuttlingen, Baden-Wuerttemberg 78532 Germany
Re: K150468
Trade/Device Name: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: February 25, 2016 Received: February 26, 2016
Dear Mr. Jung:
This letter corrects our substantially equivalent letter of February 29, 2016.
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 Actinclude 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet
address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150468
Device Name
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
Indications for Use (Describe)
Laminectomy Rongeurs, Kerrison 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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3
Image /page/3/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features a stylized "k2" in black and green, followed by the word "medical" in black. Below "medical" is the text "GmbH & Co. KG" in a smaller font size.
1. Submitter Information
| Submitter: | K2 Medical GmbH & Co. KG
Unter Buchsteig 5
D-78532 Tuttlingen
GERMANY |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory
Phone: +49 7462 94799-182
Fax: +49 7462 94799-282 |
| Date Prepared: | 12.02.2015 |
| Device Trade Name: | K2 Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs |
| Common / Usual Name: | Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs |
| Classification Name | Rongeur, Manual (21 CFR 882.4840) |
| Regulatory Class: | II |
| Product Code: | HAE |
2. Predicate Device:
| Trade name | Integra™ Kerrison Rongeurs | Instrumed Rongeur |
|---|---|---|
| 510(k) No. | K092227 | K081651 |
| 510(k) submitter / | ||
| holder | Integra LifeSciences Corporation | |
| 311 Enterprise Drive | ||
| Plainsboro, NJ 08536 USA | INSTRUMED INTERNATIONAL, INC. | |
| 626 Cooper Court | ||
| Schaumburg, IL 60173 |
3. Device Description:
K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
The devices are available with the following features:
Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate
- with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
- with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
- different shaft overall length (6 " inch to 15 " inch) -
- different sizes (1mm to 6 mm)
- different angles (up 40°, up 90°, down 90° -
- without ejector or with different types of ejectors
- with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
- traditional style or with special cleaning channel
- traditional style or with opening mechanism (convertible, take-apart)
- with rotating shaft angled 90° and 40°
4
510(k) Summary
Image /page/4/Picture/1 description: The image shows the logo for K2medical GmbH & Co. KG. The logo features the letter "K" in black, followed by a green number "2". The word "medical" is written in black to the right of the "K2", and the text "GmbH & Co. KG" is written in a smaller font size below the word "medical".
IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart
- in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
- with different length and jaw sizes
- angled and straight
- with closed jaw and with fenestrated jaws
- with smooth jaw and with teeth
Laminectomy Rongeurs with double action joints and strong handle
- Fulton Laminectomy Rongeurs -
4. Indications for Use
Laminectomy Rongeurs, Kerison 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.
5. Comparison of technological Characteristics to predicate device
| | new device | predicate
Integra K092227 | predicate
Instrumed K081651 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| indication for
use
and target
population | 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. | IntegraTM Kerrison
Rongeurs are manually
operated instruments
indicated for cutting or
biting bone during sur-
gery involving the skull or
spinal column. | The intended use of
Instrumed Rongeur is
to access, cut and
bite soft tissue and
bone during surgery
involving the spinal
column. |
| design | Kerrison style Rongeur with a fixed and a sliding
shaft and an angled footplate
IVD Rongeurs with one fixed shaft, one sliding shaft
and a hinged mouthpart
Laminectomy Rongeurs with double action joints
and strong handle | same | same |
| design | Kerrison Rongeur with cleaning channel | without cleaning channel | same |
| design | Kerrison Rongeur with pushbutton opening mecha-
nism and with lever opening mechanism | Kerrison Rongeur with
lever opening mechanism | Kerrison Rongeur
with lever opening
mechanism |
| Materials /
Biocompati-
bility | Stainless Steel AISI 420 A
Titanium acc. ASTM F136 / ISO 5832-3 | Stainless Steel | Stainless Steel
Titanium |
| | several surface coatings:
anthracite, gold, black | several decorative coat-
ings (Diamond, Stealth) | same |
| | silicone coated handle | | same |
| Cleaning | Instruments can be processed in a validated wash-
er-disinfector prior to sterilization. | same | same |
| Sterilization | non-sterile
Sterilization prior to use, using steam sterilization. | same | same |
5
Image /page/5/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features the text "k2 medical" in a sans-serif font, with the "k2" portion in a green color and the "medical" portion in black. Below the main text, in a smaller font size, is the text "GmbH & Co. KG".
6. Testing
Performance data
The following performance data were provided in support of the substantial equivalence determination:
| Test | Test Method Summary | Results |
|---|---|---|
| Automatic Repro- | ||
| cessing Validation | ||
| "Panther Kerrison | ||
| Rongeur" |
Amendment to
Automatic Repro-
cessing Validation
"Panther Kerrisson
Rongeur. | The test was performed to verify that the devices could be
cleaned with the provided cleaning steps in the IFU.
This test method is performed by contamination of accessi-
ble, interior, and exterior surfaces of instruments intending
to reach the sites identified as the least accessible or most
difficult to reach sites (worst case).
According AAMI TIR 30, the effectiveness of the repro-
cessing cycle is evaluated by comparing visible contamina-
tion (red blood cells), residual protein, the number of organ-
isms and TOC level recovered from the control instruments
and the test instruments. | This validation provides evidence
that viable microbiological contami-
nation as well as a soil contamina-
tion of the "Panther Kerrison
Rongeur" are removed by the given
cleaning and disinfection instruc-
tions |
| Sterilization testing | The test is to verify that the devices could be sterilized with
the provided sterilization procedure described in the IFU.
The test specimens were contaminated with bioindicators
or with a challenge suspension and were tested for sterility
after the sterilization process.
To assure a SAL of $10^{-6}$ only a part cycle of the recom-
mended sterilization process was performed in validation. | A reduction of test bacteria was
observed and assured showing that
contaminated test specimens are
free of viable/augmentable bacteria
after sterilization. |
| Boiling Test | This test is to verify the corrosion resistance of the instru-
ments.
It is performed according ASTM F1089-10 section 6.1.
Devices are boiled in distilled water for 30 min, cooled
down in the water for 3 h and dried at air for 2 h.
Devices were not allowed to show signs of corrosion. | The tested instruments did not show
any signs of corrosion. |
| Cytotoxic testing | Test is to show, that no toxic residuals from manufacturing
remained on the device.
The test was performed with finished devices from all the
different materials and coatings according ISO 10993-5.
Devices must be considered non cytotoxic. | All the tested samples were consid-
ered to be NON CYTOTOXIC. |
| Irritation testing | The objective of this study was to determine if device-
extracts produced an irritation reaction when injected intra-
cutaneously in rabbits.
Test was performed according ISO 10993-10 with finished
devices in all material-coating configurations.
Devices were extracted in 0.9 % saline and cottonseed Oil
for 72 h. Extracts were injected intracutaneously and site
was graded for tissue reaction at 24, 48 and 72 hours after
dose administration.
Skin irritation was evaluated according ISO 10993-10. | Test data indicated that the device
extracts did not cause a skin irrita-
tion reaction. |
| Mechanical testing
- handle force
- bite force
- extended use | Mechanical tests were performed to compare functional
requirements of the K2 Rongeurs with the predicate devic-
es.
Therefore the handle force for actuating the device was
measured as well as the force to cut artificial bone material.
Further on the cutting force and cutting size of new instru-
ments was measured and compared to worn out instru-
ments with the artificial bone material.
Devices has to perform similar or better than predicate
devices. | Test showed that the measured
functional specifications of the K2
Rongeurs were equivalent or better
than the comparable specifications
of the predicate devices. |
The nonclinical testing demonstrated, that the K2 Rongeur is substantial equivalent to the predicate device and performs as well as or better than the legally marketed predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features the letter "k" in black, followed by a green number "2". The word "medical" is written in black to the right of the "k2". Below the word "medical" is the text "GmbH & Co. KG".
7. Substantial Equivalence
Substantial equivalence for the K2 Ronqeurs is based on similarities in intended use, design (function, dimensions, operational principles and performance tests), materials and labeling based on their promotional materials, labeling and clearance letter.
The only difference to the predicate devices is another opening mechanism with a push button for the K2 Kerrison Rongeurs. By pressing the push button the upper part of the shaft can slide back and is released from the guide of the lower part. It can easily be opened for cleaning. After cleaning the upper part is laid down to the lower part and snapped in by pressing the handle.
The predicate device from Integra and from Instrumed has a lever to release the upper part from the quide of the lower part.
The minor technological differences between the K2 Rongeurs and the predicate devices raise no new issues of safety or effectiveness.
Performance data demonstrate, that the K2 Rongeurs do comply to relevant standards and that their main functional features are equivalent to the predicate devices from Integra and Instrumed. Thus, the K2 Rongeur is substantially equivalent to the predicate device.