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.

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.

AI/ML Overview

The FDA 510(k) clearance letter for the Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) indicates that it is a manual rongeur, a Class II device. The nature of this device (a surgical tool for cutting and removing bone and tissue) means that the acceptance criteria and study information typically associated with AI/ML-powered diagnostic or predictive devices are not applicable.

This device is not an AI/ML product. The document describes a traditional medical device (a surgical instrument). Therefore, many of the requested categories for acceptance criteria and study details (like expert adjudication, MRMC studies, standalone algorithm performance, training set details) are irrelevant.

Here's an interpretation based on the provided document regarding this specific traditional medical device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance
Technological Characteristics	Demonstrated substantial equivalence (identical or very similar characteristics) to predicate devices (K200768 and K221818) in terms of: - Product Code (HAE) - Class (II) - Regulation # (882.4840) - Classification Name (Manual, Rongeur) - Indication for Use (Identical) - Anatomical location (Skull and spine) - Sterility (Sterile) - Re-Use (No) - Material (Stainless Steel: 420, 304 and 302; Polymer: PVC, ABS, PA6 GF60, TPE, Fluoropolymer) - Patient Contacting Materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer) - Design features (Manual Rongeur) - Bone Removal (Suctional function) - Shaft-length (160, 200 and 250 mm) - Jaw opening (14 mm) - Bite size (2 - 4 mm) - Cutting angulation (90° up-biting) - Packaging (double packed in a PET/PP composite film) - Shelf life (packaging)
Material Biocompatibility	Patient-contacting materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer) are the same as predicate devices, implying biocompatibility acceptance.
Sterilization & Packaging Integrity	Passed shelf-life validation according to ISO 11607-1 for 5 years for the sterile barrier system (SBS). Predicate device had a 2-year shelf-life, and the subject device improved this to 5 years.
Device Functionality/Performance	The subject device does not represent a new worst-case compared to predicate devices (K200768 and K221818), implying comparable cutting and bone/tissue removal functionality.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical surgical instrument, not a data-driven system. Testing would involve physical devices. The non-clinical performance mentioned refers to evaluating the sterile barrier system and comparing material/design characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic/AI devices, refers to an agreed-upon clinical truth. For a surgical instrument, the "truth" is its ability to perform its intended mechanical function and safety characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a traditional manual surgical tool, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense of AI/diagnostic devices. For this device, "ground truth" relates to the physical and material properties meeting established standards and being equivalent to predicate devices. This is established through engineering and physical tests (material testing, sterilization validation, dimensional checks) rather than clinical "ground truth" derived from patient data.

8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML product that undergoes training.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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)

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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

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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	RegulationDescription	RegulationMedical Specialty	Product Code	RegulationNumber	DeviceClassification
Rebellion	Manual rongeur	Neurology	HAE	21 CFR882.4840	II

3 Predicate Device / Reference Device

Subject Device	Predicate Device	Reference Device	510(k) number	510(k) Holder
Rebellion	Rebellion;Phantom Multi-BiteKerrison Rongeur	—	K200768 K221818	Morpheus AG

Device Description 4

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".

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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 DeviceMorpheus 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 andremoving bone, vertebral bodies and tissuein orthopedics, neurosurgery and spinesurgery 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 302Polymer: PVC, ABS, PA6 GF60 (Grivory GV-6H); TPE (TM5MED) and Fluoropolymer(Altera MT1000A)	Stainless Steel: 420, 304 and 302Polymer: PVC, ABS, PA6 GF60 (GrivoryGV-6H); TPE (TM5MED) and Fluoropolymer(Altera MT1000A)
Patient Contacting	Stainless Steel: 420, 304Polymer: Fluoropolymer (Altera MT1000A)	Stainless Steel: 420, 304Polymer: 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 (sterilebarrier 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

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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).

Regulation Number and Section

§ 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).