(106 days)
No
The device description and other sections do not mention any AI or ML capabilities; it describes a mechanical bone punch with a rinsing mechanism.
No.
The device is intended for cutting and removing bone and tissue, which is an interventional surgical function rather than a therapeutic one.
No
The device is used for cutting and removing bone and tissue, which is a therapeutic or surgical function, not a diagnostic one. It does not analyze data or provide information about the patient's condition.
No
The device description clearly describes a physical surgical instrument (Bone Punch) with specific dimensions, tip sizes, and connections for rinsing and suction. This is a hardware device, not software.
Based on the provided information, the Rebellion device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 during a procedure.
- Device Description: The description details a "Bone Punch" with specific physical characteristics and 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, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly manipulate tissue during surgery.
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 160 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
Non-Clinical performance testing: The subject device does not represent a new worst-case when compared to the previously cleared Morpheus Rebellion Rongeur (K200768). Clinical performance testing was not submitted in this 510(k).
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 contains 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.
October 7, 2022
Morpheus AG Timo Rack, CEO Bahnhofstraße 18 Spaichingen, Baden Würrtemberg 78549 Germany
Re: K221818
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: August 30, 2022 Received: September 8, 2022
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221818
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)
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3
Morpheus AG Rebellion 510(k) Premarket Notification
Image /page/3/Picture/2 description: The image is a logo for Morpheus AG, a company that specializes in inspiring medical technology. The logo features a stylized head with a pixelated effect on the right side, followed by the company name "MORPHEUS AG" in bold, sans-serif font. Below the company name, the tagline "INSPIRING MEDICAL TECHNOLOGY" is written in a smaller, sans-serif font.
DATE OF APPLICATION: 10/07/2022
APPLICANT:
Morpheus AG Bahnhofstrasse 18 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
Image /page/4/Picture/2 description: The image shows the logo for Morpheus AG. The logo consists of a stylized head in profile on the left, with a series of squares emanating from the back of the head. To the right of the head is the text "MORPHEUS AG" in bold, followed by the text "INSPIRING MEDICAL TECHNOLOGY" in a smaller font.
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 | Rebellion; | |||
| Phantom Multi-Bite | ||||
| Kerrison Rongeur | -- | K200768 | Morpheus AG | |
| -- | Fehling-punches | K153243 | Fehling Instruments | |
| GmbH & Co. KG |
4 Device Description
The Rebellion is a Bone Punch and it is available in the length 160 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/Picture/12 description: The image shows a tool that is labeled as "Figure 1: Rebellion". The tool has a long, white barrel with a black handle and trigger. There is also a gray cable coming out of the handle.
Figure 1: Rebellion
5
Morpheus AG Rebellion 510(k) Premarket Notification
Image /page/5/Picture/2 description: The image shows the logo for Morpheus AG, a company focused on inspiring medical technology. The logo features a stylized silhouette of a human head in profile, with a pixelated or fragmented design emanating from the back of the head. To the right of the head is the company name, "MORPHEUS AG," in bold, sans-serif font, with the tagline "INSPIRING MEDICAL TECHNOLOGY" underneath in a smaller font size.
Intended 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.
Technological Characteristics e
Morpheus Rebellion possesses similar technological characteristics as compared to the predicate device K200768 and reference device K153243. 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) | Reference Device
Fehling Instruments GmbH
& Co. KG
(Fehling-punches) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | -- | K200768 | K153243 |
| 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. | 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. |
| Anatomical
location | Skull and spine | Skull and spine | Skull and spine |
| Sterility | Sterile | Sterile | Non-Sterile |
| Re-Use | No | No | Yes |
| 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) | 420 and 304 Stainless
Steels;
Coating: CERAMO®
(TiAIN)
Polymer: Silicone |
| Patient
Contacting | Stainless Steel: 420, 304
Polymer: Fluoropolymer (Altera
MT1000A) | Stainless Steel: 420, 304
Polymer: Fluoropolymer
(Altera MT1000A) | 420 and 304 Stainless
Steels; CERAMO® (TiAIN) |
| Design features | Manual Rongeur | Manual Rongeur | Manual Rongeur |
| Bone Removal | Suctional function | Suctional function | Manual |
| Shaft-length | 160 mm | 200 - 250 mm | 110 - 400 mm |
| Jaw opening | 14 mm | 14 mm | 9 - 19 mm |
| Bite size | 2 - 4 mm | 2 - 4 mm | 0.8 - 8 mm |
| Description | Subject Device | Predicate Device
Morpheus AG
(Rebellion) | Reference Device
Fehling Instruments GmbH
& Co. KG
(Fehling-punches) |
| Cutting
angulation | 90° up-biting | 90° up-biting | 40° and 90° up/down bi-
ting |
6.1 Device Characteristics Table
6
Morpheus AG Rebellion 510(k) Premarket Notification
Image /page/6/Picture/2 description: The image shows the logo for Morpheus AG, a company focused on inspiring medical technology. The logo features a stylized silhouette of a human head with a pixelated effect emanating from the back of the head. To the right of the head is the company name "MORPHEUS AG" in bold, uppercase letters, with the tagline "INSPIRING MEDICAL TECHNOLOGY" underneath in a smaller font.
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).
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 device, the Rebellion Rongeur (K200768).