(106 days)
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.
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.
The provided text is a 510(k) premarket notification for a medical device called the "Rebellion; Phantom Multi-Bite Kerrison Rongeur." This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a study.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance from a study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone algorithm performance study.
- Type of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document states:
Acceptance Criteria and Study that Proves the Device Meets Acceptance Criteria:
The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission. The "study" in this context is the comparison presented in the 510(k) itself.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of acceptance criteria in the typical sense of numerical thresholds for performance metrics. Instead, it compares the technological characteristics of the subject device (Rebellion; Phantom Multi-Bite Kerrison Rongeur) to its predicate device (Rebellion, K200768) and a reference device (Fehling-punches, K153243) to demonstrate substantial equivalence. The "performance" is implicitly demonstrated through this comparison and non-clinical testing.
The table below summarizes the comparison of characteristics, which are implicitly the "criteria" for substantial equivalence:
| Characteristic | Subject Device (Rebellion) | Predicate Device (Morpheus AG Rebellion, K200768) | Reference Device (Fehling Instruments GmbH & Co. KG Fehling-punches, K153243) |
|---|---|---|---|
| 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 intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery 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 |
| Cutting angulation | 90° up-biting | 90° up-biting | 40° and 90° up/down biting |
The document concludes that the "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."
Non-Clinical Performance Testing:
The document states: "The subject device does not represent a new worst-case when compared to the previously cleared Morpheus Rebellion Rongeur (K200768)." This implies that previous non-clinical testing for the predicate device is considered sufficient, and the new device performs at least as well or does not introduce new risks.
7.1 Clinical performance testing:
"Clinical performance testing was not submitted in this 510(k)."
Disclaimer: This response is based solely on the provided text. The document is for a 510(k) submission, which often relies on substantial equivalence rather than extensive clinical efficacy studies to demonstrate safety and effectiveness for Class II devices.
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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
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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 Quality Center for Devices and Radiological Health
Enclosure
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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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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
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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 | 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 | Rebellion;Phantom Multi-BiteKerrison Rongeur | -- | K200768 | Morpheus AG |
| -- | Fehling-punches | K153243 | Fehling InstrumentsGmbH & 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
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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 DeviceMorpheus AG(Rebellion) | Reference DeviceFehling 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 |
| 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. | The Rebellion is indicated tocut and remove bone,vertebral body and tissue inthe orthopedic, neuro andspine surgery involving theskull or spinal column. | Fehling rongeurs (bonepunches) are manuallyoperated instrumentsindicated for cutting orbiting bone during surgeryinvolving the skull orspinal column. |
| Anatomicallocation | Skull and spine | Skull and spine | Skull and spine |
| Sterility | Sterile | Sterile | Non-Sterile |
| Re-Use | No | No | Yes |
| Material | Stainless Steel: 420, 304 and302Polymer: PVC, ABS, PA6 GF60(Grivory GV-6H); TPE(TM5MED) and Fluoropolymer(Altera MT1000A) | Stainless Steel: 420, 304 and302Polymer: PVC, ABS, PA6 GF60(Grivory GV-6H); TPE(TM5MED) and Fluoropolymer(Altera MT1000A) | 420 and 304 StainlessSteels;Coating: CERAMO®(TiAIN)Polymer: Silicone |
| PatientContacting | Stainless Steel: 420, 304Polymer: Fluoropolymer (AlteraMT1000A) | Stainless Steel: 420, 304Polymer: Fluoropolymer(Altera MT1000A) | 420 and 304 StainlessSteels; 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 DeviceMorpheus AG(Rebellion) | Reference DeviceFehling Instruments GmbH& Co. KG(Fehling-punches) |
| Cuttingangulation | 90° up-biting | 90° up-biting | 40° and 90° up/down bi-ting |
6.1 Device Characteristics Table
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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).
§ 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).