(405 days)
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device 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, not a device that provides therapy or treats a condition.
No
Explanation: The device is described as a "Bone Punch" intended for "cutting and removing bone, vertebral bodies and tissue." This is an active surgical instrument, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical bone punch with different lengths and tip sizes, and connections for rinsing and suction. This is a hardware device.
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 and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a "Bone Punch" with physical characteristics (lengths, tip sizes, connections for rinsing and suction). This is consistent with a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The Rebellion is a surgical tool used for physical manipulation of tissue during a procedure.
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 two lengths (200 – 250 mm) with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. 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
Clinical performance testing was not submitted in this 510(k). To verify function and performance under simulated environmental and application conditions, a cadaver test was performed in an operating room with two potential users. A product validation was also performed in which the product was tested up to the maximum life cycle by cutting simulated bone.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 4, 2021
Morpheus AG Timo Rack CEO Bahnhofstrasse 20 Spaichingen. 78549 DE
Re: K200768
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: March 29, 2021 Received: April 2, 2021
Dear Timo Rack:
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200768
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 CER 801 Subpart D) | Over-The-Counter Use (21 C.FR 801 Subnart C) |
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Morpheus AG Rebellion 510(k) Premarket Notification
| DATE: | 05/04/2021 |
|---|---|
| 510(k) Number: | K200768 |
| APPLICANT: | Morpheus AG Bahnhofstrasse 20 78549 Spaichingen Germany Tel: + 49 (0) 7461 70382-0 E-Mail: info@morpheus.com.ag |
| CONTACT PERSON: | Timo Rack CEO Tel.: + 49 (0) 7461 70382-11 E- Mail: t.rack@morpheus.com.ag |
4
Morpheus AG Rebellion 510(k) Premarket Notification
1 Device Name
| 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 |
Predicate Device / Reference Device 3
| Subject Device | Predicate Device | Reference Device | 510(k) number | 510(k) Holder |
|---|---|---|---|---|
| Rebellion | Fehling Punches | -- | K153243 | Fehling Instruments |
| GmbH & Co. KG | ||||
| -- | Steribite | K180949 | RJR Surgical, Inc. |
Device Description 4
The Rebellion is a Bone Punch and it is available in two lengths (200 – 250 mm) with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. 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/11 description: The image shows a tool labeled as "Figure 1: Rebellion". The tool has a long, white barrel with a black handle and trigger mechanism. A thin, flexible tube is connected to the back of the handle.
은 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.
5
Morpheus AG
Rebellion 510(k) Premarket Notification
6 Technological Characteristics
Morpheus Rebellion possesses similar technological characteristics as compared to the predicate device K153243 and reference device K180949.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.
6.1 Device Characteristics Table
| Description | Subject Device | Predicate Device
Fehling Instruments GmbH &
Co. KG
(Fehling-punches) | Reference Device
RJR Surgical, Inc.
(Steribite) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | -- | K153243 | K180949 |
| Product Code | HAE | HAE | HAE |
| Class | II | II | II |
| Regulation # | 882.4840 | 882.4840 | 882.4840 |
| Classification
Name | Manual, Rongeur | Manual, Rongeur | Manual, Rongeur |
| Indication for Use | The Rebellion is indicated to cut
and remove bone, vertebral
body and tissue in the
orthopedic, neuro and spine
surgery involving the skull or
spinal column. | Fehling rongeurs (bone
punches) are manually
operated instruments
indicated for cutting or biting
bone during surgery involving
the skull or spinal column. | The Steribite® Rongeur is
a manually operated
instrument indicated for
cutting or biting bone
during surgery involving
the skull or spinal column. |
| Anatomical
location | Skull and spine | Skull and spine | Skull and spine |
| Sterility | Sterile | Non-Sterile | Sterile |
| Re-Use | No | Yes | No |
| Material | Stainless Steel: 420, 304 and
302
Polymer: PVC, ABS, PA6 GF60
(Grivory GV-6H); TPE
(TM5MED) and Fluoropolymer
(Altera MT1000A) | 420 and 304 Stainless Steels;
Coating: CERAMO® (TiAIN)
Polymer: Silicone | 420, 17- 4PH, 302 and
316 stainless steel;
Polymer: polyarylamide
resin |
| Patient
Contacting | Stainless Steel: 420, 304
Polymer: Fluoropolymer (Altera
MT1000A) | 420 and 304 Stainless Steels;
CERAMO® (TiAIN) | 420 and 17- 4PH stainless
steel |
| Design features | Manual Rongeur | Manual Rongeur | Manual Rongeur |
| Bone Removal | Suction | Manual | Manual |
| Shaft-length | 200 - 250 mm | 110 - 400 mm | 200 - 280 mm |
| Jaw opening | 14 mm | 9 - 19 mm | Not known |
| Bite size | 2 - 4 mm | 0.8 - 8 mm | 1 - 5 mm |
| Cutting
angulation | 90° up-biting | 40° and 90° up/down biting | 40° up-biting |
6
Morpheus AG Rebellion 510(k) Premarket Notification
7 Performance Data
7.1 Clinical performance testing
Clinical performance testing was not submitted in this 510(k).
7.2 Biocompatibility
The Morpheus Rebellion is categorized as an external communicating device with limited contact (≤24 h) with tissue/bone. The appropriate biocompatibility endpoints that were assessed include:
- Cytotoxicity
- Sensitization
- . Irritation or Intracutaneous Reactivity
- . Acute Systematic Toxicity
- Material-Mediated Pyrogenicity
- . Hemocompatibility
7.3 Sterilization
Sterilization validation was conducted in accordance with ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
7.4 Packaging and Shelf Life
Packaging and Shelf Life validation was conducted in accordance with ISO 11607:2017, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.
7.5 Functional performance data
To verify function and performance under simulated environmental and application conditions, a cadaver test was performed in an operating room with two potential users.
A product validation was also performed in which the product was tested up to the maximum life cycle by cutting simulated bone.
8 Conclusion
Morpheus Rebellion possesses indications for use and technological characteristics similar to the predicate devices. The performance testing demonstrated that the device is as safe and effective as the predicate and has equivalent performance to the predicate. Therefore, Morpheus Rebellion is substantially equivalent to the predicate.