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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called "Rebellion, Phantom Multi-Bite Kerrison Rongeur." The FDA has reviewed and determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values for clinical efficacy. Instead, it describes performance testing related to safety and functionality. Since this is a non-AI based device, the acceptance criteria are focused on demonstrating substantial equivalence to predicate devices in areas like material safety, sterilization, packaging, and basic function. While specific numerical acceptance criteria aren't provided in the same way they would be for an AI device (e.g., sensitivity/specificity thresholds), the document implies acceptance by stating that the device meets the requirements of the standards and passes the tests.

Type of Test/Criterion	Acceptance Implication	Reported Device Performance
Clinical Performance	Not applicable; no clinical testing submitted for 510(k).	No clinical performance data provided in this 510(k).
Biocompatibility	Device must meet ISO 10993 requirements for external communicating devices with limited contact (≤24 h).	Assessed endpoints: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systematic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility. (Implied successful completion by FDA clearance)
Sterilization	Device must be sterilized according to ISO 11135:2014.	Validation conducted in accordance with ISO 11135:2014. (Implied successful completion by FDA clearance)
Packaging & Shelf Life	Device packaging and shelf life must be validated according to ISO 11607:2017.	Validation conducted in accordance with ISO 11607:2017. (Implied successful completion by FDA clearance)
Functional Performance (Cadaver Test)	Device must demonstrate function and performance under simulated environmental and application conditions by potential users.	A cadaver test was performed in an operating room with two potential users. (Implied successful demonstration of function)
Functional Performance (Product Validation)	Device must perform up to the maximum life cycle, cutting simulated bone.	Product validation performed, testing the product up to maximum life cycle by cutting simulated bone. (Implied successful demonstration of function)

2. Sample Size Used for the Test Set and Data Provenance

Cadaver Test: The document states that a cadaver test was performed with "two potential users." The sample size for cadavers is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).
Product Validation (Simulated Bone): The document mentions "maximum life cycle by cutting simulated bone." No sample size for the simulated bone tests or data provenance is provided.
Biocompatibility, Sterilization, Packaging & Shelf Life: These would involve specific test samples as defined by the respective ISO standards, but the document does not detail the sample sizes used in those validations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly provided.

For the cadaver test, "two potential users" were involved, implying they were experts in orthopedic, neurosurgery, or spine surgery. However, their specific qualifications (e.g., years of experience, board certification) are not detailed.
For other tests (biocompatibility, sterilization, etc.), ground truth is established by adherence to recognized international standards and testing methodologies, not typically by expert consensus on specific cases.

4. Adjudication Method for the Test Set

This information is not explicitly provided. For the functional tests (cadaver and simulated bone), it's implied that the "potential users" or test operators observed and evaluated the device's performance, but no formal adjudication method (like 2+1 or 3+1 consensus) is described. Since this is a mechanical device, ground truth for its function would be based on its physical performance metrics rather than interpretation of medical images or diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a manual rongeur, not an AI-assisted diagnostic tool. Therefore, studies comparing AI with and without human assistance are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This is a physical, manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

Functional Performance (Cadaver Test & Simulated Bone): The ground truth for functional performance would primarily be the direct observation of the device's ability to cut and remove bone/tissue as intended, without failure or malfunction, under simulated surgical conditions. This is an objective assessment of the device's mechanical integrity and operational effectiveness.
Biocompatibility, Sterilization, Packaging: Ground truth for these aspects is established by compliance with published international standards (ISO 10993, ISO 11135, ISO 11607, respectively). The tests performed according to these standards provide objective evidence of safety and performance.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. Since this is a physical medical device (a manual rongeur) and not an AI/software device, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and is not provided, as there is no training set for this type of device.

Summary

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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

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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

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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

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

Predicate Device / Reference Device 3

Subject Device	Predicate Device	Reference Device	510(k) number	510(k) Holder
Rebellion	Fehling Punches	--	K153243	Fehling InstrumentsGmbH & Co. KG
	--	Steribite	K180949	RJR Surgical, Inc.

Device Description 4

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.

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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 DeviceFehling Instruments GmbH &Co. KG(Fehling-punches)	Reference DeviceRJR Surgical, Inc.(Steribite)
510(k)	--	K153243	K180949
Product Code	HAE	HAE	HAE
Class	II	II	II
Regulation #	882.4840	882.4840	882.4840
ClassificationName	Manual, Rongeur	Manual, Rongeur	Manual, Rongeur
Indication for Use	The Rebellion is indicated to cutand remove bone, vertebralbody and tissue in theorthopedic, neuro and spinesurgery involving the skull orspinal column.	Fehling rongeurs (bonepunches) are manuallyoperated instrumentsindicated for cutting or bitingbone during surgery involvingthe skull or spinal column.	The Steribite® Rongeur isa manually operatedinstrument indicated forcutting or biting boneduring surgery involvingthe skull or spinal column.
Anatomicallocation	Skull and spine	Skull and spine	Skull and spine
Sterility	Sterile	Non-Sterile	Sterile
Re-Use	No	Yes	No
Material	Stainless Steel: 420, 304 and302Polymer: 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 and316 stainless steel;Polymer: polyarylamideresin
PatientContacting	Stainless Steel: 420, 304Polymer: Fluoropolymer (AlteraMT1000A)	420 and 304 Stainless Steels;CERAMO® (TiAIN)	420 and 17- 4PH stainlesssteel
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
Cuttingangulation	90° up-biting	40° and 90° up/down biting	40° up-biting

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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.

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).