(31 days)
No
The device description and performance studies do not mention any AI or ML capabilities. It is a mechanical bone punch.
No.
The device is described as a Bone Punch intended for cutting and removing bone and tissue, which is a surgical tool rather than a device designed for therapy.
No
The device description indicates its use for "cutting and removing bone, vertebral bodies and tissue," which is a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly describes a physical surgical instrument (Bone Punch) with different lengths and tip sizes, designed for cutting and removing bone and tissue. It also mentions connecting to a bone and tissue trap or suction system via sterile tubing, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and removing bone, vertebral bodies and tissue" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description confirms it's a "Bone Punch" used for physical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, the Rebellion is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
Product codes
HAE
Device Description
The REBELLION is a Bone Punch and it is available in the length 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skull and spine
Indicated Patient Age Range
Not Found
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
Non-Clinical performance testing:
The subject device does not represent a new worst-case when compared to the previously cleared Morpheus REBELLION Rongeur (K200768 and K221818).
To verify the shelf life of the sterile barrier system (SBS), a shelf-life validation according to ISO 11607-1 was performed for 5 years.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 3, 2023
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Morpheus AG Dimitri Krutsch QM / RA Manager Bahnhofstraße 18 Spaichingen, Baden Würrtemberg 78549 Germany
Re: K230256
Trade/Device Name: Rebellion, Phantom Multi-Bite Kerrison Rongeur Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: January 30, 2023 Received: January 31, 2023
Dear Dimitri Krutsch:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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).
Sincerelv.
Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 0ate: 2023.03.03.03
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230256
Device Name
Rebellion, Phantom Multi-Bite Kerrison Rongeur
Indications for Use (Describe)
The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| DATE OF APPLICATION: | 01/30/2023 |
|---|---|
| 510(k) Number: | K230256 |
APPLICANT:
Morpheus AG Bahnhofstrasse 18 78549 Spaichingen Germany Tel: + 49 (0) 7461 70382-0 E-Mail: info@morpheus.com.ag
UUNIAUI PEKSUN:
Dimitri Krutsch QM / RA Manager Tel.: +497424 60 99 613 E-Mail: d.krutsch@morpheus.com.ag
4
Device Name 1
| Trade Name: | Rebellion;
Phantom Multi-Bite Kerrison Rongeur | | |
|-----------------------------|---------------------------------------------------|--|--|
| Common Name: | Kerrison Rongeur | | |
| Device Classification Name: | Manual rongeur | | |
Classification / Product Code 2
Rebellion can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical Specialty | Product Code | Regulation
Number | Device
Classification |
|-----------|---------------------------|---------------------------------|--------------|----------------------|--------------------------|
| Rebellion | Manual rongeur | Neurology | HAE | 21 CFR
882.4840 | II |
3 Predicate Device / Reference Device
| Subject Device | Predicate Device | Reference Device | 510(k) number | 510(k) Holder |
|---|---|---|---|---|
| Rebellion | Rebellion; | |||
| Phantom Multi-Bite | ||||
| Kerrison Rongeur | — | K200768 | ||
| K221818 | Morpheus AG |
Device Description 4
The REBELLION is a Bone Punch and it is available in the length 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
Image /page/4/Figure/10 description: The image shows a black and green tool with a long, thin black shaft. The handle of the tool is black with green accents and has a trigger-like design. The shaft extends from the handle and has a small, silver-colored tip. The text at the bottom of the image says "Figure 1: Rebellion".
5
Indications For Use 5
The REBELLION is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
e Technological Characteristics
Morpheus Rebellion possesses similar technological characteristics as compared to the predicate device K200768 and K221818. Different characteristics do not raise different questions of safety and effectiveness, and scientific methods were applied to evaluate different characteristics' effects on safety and effectiveness.
| Description | Subject Device | Predicate Device
Morpheus AG
(Rebellion) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K230256 | K200768
K221818 |
| Product Code | HAE | HAE |
| Class | II | II |
| Regulation # | 882.4840 | 882.4840 |
| Classification Name | Manual, Rongeur | Manual, Rongeur |
| Indication for Use | Identical | The Rebellion is intended for cutting and
removing bone, vertebral bodies and tissue
in orthopedics, neurosurgery and spine
surgery involving the skull or spinal column. |
| Anatomical location | Skull and spine | Skull and spine |
| Sterility | Sterile | Sterile |
| Re-Use | No | No |
| Material | Stainless Steel: 420, 304 and 302
Polymer: PVC, ABS, PA6 GF60 (Grivory GV-
6H); TPE (TM5MED) and Fluoropolymer
(Altera MT1000A) | Stainless Steel: 420, 304 and 302
Polymer: PVC, ABS, PA6 GF60 (Grivory
GV-6H); TPE (TM5MED) and Fluoropolymer
(Altera MT1000A) |
| Patient Contacting | Stainless Steel: 420, 304
Polymer: Fluoropolymer (Altera MT1000A) | Stainless Steel: 420, 304
Polymer: Fluoropolymer (Altera MT1000A) |
| Design features | Manual Rongeur | Manual Rongeur |
| Bone Removal | Suctional function | Suctional function |
| Shaft-length | 160, 200 and 250 mm | 160, 200 and 250 mm |
| Jaw opening | 14 mm | 14 mm |
| Bite size | 2 - 4 mm | 2 - 4 mm |
| Cutting angulation | 90° up-biting | 90° up-biting |
| Packaging (sterile
barrier system) | double packed in a PET/PP composite film | double packed in a PET/PP composite film |
| Shelf life (packaging) | 5 years | 2 years |
6.1 Device Characteristics Table
6
Performance Data 7
7.1 Clinical performance testing
Clinical performance testing was not submitted in this 510(k).
7.2 Non-Clinical performance testing
The subject device does not represent a new worst-case when compared to the previously cleared Morpheus REBELLION Rongeur (K200768 and K221818).
To verify the shelf life of the sterile barrier system (SBS), a shelf-life validation according to ISO 11607-1 was performed for 5 years.
Conclusion 8
In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Morpheus AG concludes that the Rebellion Rongeur is as safe and as effective for their intended use as the predicate devices, the Rebellion Rongeur (K200768 and K221818).