(30 days)
Not Found
No
The device description focuses on measuring angles relative to gravity using sensors and displaying them via a mobile application. There is no mention of AI/ML algorithms for analysis, interpretation, or decision support. The device explicitly states it does not provide surgical assistance, guidance, or navigation against patient anatomy and is not intended to replace surgeon judgment.
No
The device is described as an intraoperative surgical angle measurement guide that measures the angle of surgical instruments. It explicitly states that it "does not provide surgical assistance, guidance, or navigation against patient anatomy" and "is not intended to replace a surgeon's clinical judgement." Furthermore, it mentions that "No clinical benefit has been demonstrated or is claimed," indicating it does not directly treat or diagnose a condition.
No
This device measures the angle of surgical instruments relative to a plumb line for guidance in pedicle screw implantation and explicitly states it "does not provide surgical assistance, guidance, or navigation against patient anatomy" and "is not intended to replace a surgeon's judgment." It does not diagnose any medical condition or disease.
No
The device description explicitly lists hardware components (RJB Device, handles, probes) that are part of the system, in addition to the software application.
Based on the provided information, the Ruthless Spine RJB device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Ruthless Spine RJB Function: The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide. It measures the angle of surgical instruments relative to gravity during a surgical procedure. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use is to assist in lumbosacral pedicle screw implantation by providing angle measurements of surgical instruments. This is a surgical aid, not a diagnostic test performed on a biological sample.
Therefore, the Ruthless Spine RJB device falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
Product codes
QWL
Device Description
The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system:
- RJB Device
- Quick Connect Axial Ratcheting Handle
- Straight Probe
- Duckbill Probe
- RJB Application
Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Non-Clinical:
There were no changes to the design, intended use, or principles of operation. Therefore, performance testing was not required. The predicate device performance data is applicable to the subject device.
Performance Testing - Clinical:
Clinical testing was not applicable to support a substantial equivalence determination for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEN230012 – Ruthless Spine RJB
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
November 29, 2024
Ruthless, LLC dba Ruthless Spine % Kyle Kovach Sr. Quality and Regulatory Engineer JALEX Medical. LLC 27865 Clemens Road Westlake, Ohio 44145
Re: K243375
Trade/Device Name: Ruthless Spine RJB Regulation Number: 21 CFR 888.4560 Regulation Name: Intraoperative Surgical Angle Measurement Tool Regulatory Class: Class II Product Code: QWL Dated: October 30, 2024 Received: October 30, 2024
Dear Kyle Kovach:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Ruthless Spine RJB
Indications for Use (Describe)
The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows a logo for "Ruthless Spine". The logo features a stylized image of a spine that resembles a scorpion. The spine curves into an "S" shape, with the top part resembling a scorpion's tail and the bottom part resembling a scorpion's body and legs.
510(k) Summary
| Applicant: | Ruthless, LLC dba Ruthless Spine
1438 Arrow Highway
Ste F
Irwindale, CA 91706 |
|-----------------------------|----------------------------------------------------------------------------------------|
| Date: | 10/30/2024 |
| Contact Person: | Kyle Kovach, Sr. Quality and Regulatory Engineer |
| Contact Telephone: | (440) 787-5832 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Ruthless Spine RJB |
| Common Name: | Intraoperative Surgical Angle Measurement Tool |
| Device Classification Name: | 21 CFR 888.4560 |
| Device Class: | II |
| Reviewing Panel: | Orthopedic |
| Product Code: | QWL |
| Primary Predicate Device: | DEN230012 – Ruthless Spine RJB |
Device Description:
The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system:
- RJB Device
- Quick Connect Axial Ratcheting Handle
- Straight Probe
- Duckbill Probe
- RJB Application
Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.
5
Image /page/5/Picture/0 description: The image shows a logo for "Ruthless Spine". The logo features a stylized image of a spine resembling a scorpion. The spine curves in an "S" shape, with a skull at the base and a stinger at the end. The text "RUTHLESS SPINE" is written in a simple font below the image.
Indications for Use:
The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
Description of Modifications:
The Ruthless Spine RJB instruments were modified from single-use disposable to reusable. There have been no changes to the RJB or RJB software application.
Summary of Technological Characteristics
The subject Ruthless Spine RJB has the same intended use, indications for use, and technological characteristics as the predicate system.
| Subject Device | Predicate Device | ||||
|---|---|---|---|---|---|
| Item | Ruthless Spine RJB | Ruthless Spine RJB | |||
| (DEN230012) | Equivalence | ||||
| Classification | |||||
| Name | Intraoperative Surgical Angle | ||||
| Measurement Tool | Intraoperative Surgical Angle | ||||
| Measurement Tool | Identical | ||||
| Regulation | 21 CFR 888.4560 | 21 CFR 888.4560 | Identical | ||
| Product Code | QWL | QWL | Identical | ||
| Indications | |||||
| for Use | The Ruthless Spine RJB device is | ||||
| intended to measure the angle of | |||||
| surgical instruments in two planes | |||||
| relative to a vertical plumb line in | |||||
| line with gravity. It is indicated | |||||
| for use during lumbosacral | |||||
| pedicle screw implantation in | |||||
| conjunction with applicable spinal | |||||
| instrumentation and as an adjunct | |||||
| to fluoroscopy or intraoperative x- | |||||
| ray. The RJB device is not | |||||
| intended to replace a surgeon's | |||||
| judgment and has not undergone | |||||
| clinical evaluation. No clinical | |||||
| benefit has been demonstrated or | |||||
| is claimed. | The Ruthless Spine RJB device is | ||||
| intended to measure the angle of | |||||
| surgical instruments in two planes | |||||
| relative to a vertical plumb line in | |||||
| line with gravity. It is indicated | |||||
| for use during lumbosacral | |||||
| pedicle screw implantation in | |||||
| conjunction with applicable spinal | |||||
| instrumentation and as an adjunct | |||||
| to fluoroscopy or intraoperative x- | |||||
| ray. The RJB device is not | |||||
| intended to replace a surgeon's | |||||
| judgment and has not undergone | |||||
| clinical evaluation. No clinical | |||||
| benefit has been demonstrated or | |||||
| is claimed. | Identical | ||||
| Device | |||||
| Description | The Ruthless Spine RJB device is | ||||
| an intraoperative surgical angle | |||||
| measurement guide that attaches | |||||
| to surgical instruments to measure | |||||
| the angle of the instrument | The Ruthless Spine RJB device is | ||||
| an intraoperative surgical angle | |||||
| measurement guide that attaches | |||||
| to surgical instruments to measure | |||||
| the angle of the instrument | Identical |
6
Image /page/6/Picture/0 description: The image shows a logo for "Ruthless Spine". The logo features a stylized spine in the shape of an "S", with a skull at the bottom and a scorpion tail at the top. The text "RUTHLESS SPINE" is written in a bold, sans-serif font below the spine graphic.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Item | Ruthless Spine RJB | Ruthless Spine RJB | |
| (DEN230012) | Equivalence | ||
| relative to a vertical plumb line in | |||
| line with gravity. The device can | |||
| measure the axial and sagittal | |||
| angles relative to gravity. The | |||
| RJB system only provides | |||
| measurements for angles in two | |||
| planes relative to the vertical | |||
| gravitational plumb line. As such, | |||
| the RJB device does not provide | |||
| surgical assistance, guidance, or | |||
| navigation against patient | |||
| anatomy. The RJB device is not | |||
| intended to replace a surgeon's | |||
| clinical judgement and has not | |||
| undergone clinical evaluation. | |||
| No clinical benefit has been | |||
| demonstrated or is claimed. | |||
| The RJB device is provided | |||
| sterile for single use and utilizes | |||
| Bluetooth Low Energy (BLE) to | |||
| connect to a tablet computer and | |||
| display the angle measurements | |||
| via the RJB Application (App). A | |||
| set of handles and instruments | |||
| compatible with the RJB are | |||
| provided with the device for use | |||
| in lumbosacral pedicle screw | |||
| placement. The following | |||
| components are part of the RJB | |||
| system: | relative to a vertical plumb line in | ||
| line with gravity. The device can | |||
| measure the axial and sagittal | |||
| angles relative to gravity. The | |||
| RJB system only provides | |||
| measurements for angles in two | |||
| planes relative to the vertical | |||
| gravitational plumb line. As such, | |||
| the RJB device does not provide | |||
| surgical assistance, guidance, or | |||
| navigation against patient | |||
| anatomy. The RJB device is not | |||
| intended to replace a surgeon's | |||
| clinical judgement and has not | |||
| undergone clinical evaluation. | |||
| No clinical benefit has been | |||
| demonstrated or is claimed. | |||
| The RJB device is provided | |||
| sterile for single use and utilizes | |||
| Bluetooth Low Energy (BLE) to | |||
| connect to a tablet computer and | |||
| display the angle measurements | |||
| via the RJB Application (App). A | |||
| set of handles and instruments | |||
| compatible with the RJB are | |||
| provided with the device for use | |||
| in lumbosacral pedicle screw | |||
| placement. The following | |||
| components are part of the RJB | |||
| system: | |||
| • RJB Device | |||
| • Quick Connect Axial | |||
| • Ratcheting Handle | |||
| • Straight Probe | |||
| • Duckbill Probe | |||
| • RJB Application | • RJB Device | ||
| • Quick Connect Axial | |||
| • Ratcheting Handle | |||
| • Straight Probe | |||
| • Duckbill Probe | |||
| • RJB Application | |||
| Subject Device | Predicate Device | ||
| Item | Ruthless Spine RJB | Ruthless Spine RJB | |
| (DEN230012) | Equivalence | ||
| required to operate the device. | |||
| The Tablet is not provided to the | |||
| end user. | required to operate the device. | ||
| The Tablet is not provided to the | |||
| end user. | |||
| Instrument | |||
| Materials | Stainless steel, aluminum | Stainless steel, aluminum | Identical |
| Sterilization | |||
| Methods | Ethylene oxide, steam | Ethylene oxide, steam | Identical |
7
Image /page/7/Picture/0 description: The image shows a logo for "Ruthless Spine". The logo features a stylized scorpion with a human skull for its head and a spine forming the scorpion's tail. The words "RUTHLESS SPINE" are written in a bold, sans-serif font below the scorpion image.
Performance Testing - Non-Clinical:
There were no changes to the design, intended use, or principles of operation. Therefore, performance testing was not required. The predicate device performance data is applicable to the subject device.
Performance Testing - Clinical:
Clinical testing was not applicable to support a substantial equivalence determination for the subject device.
Conclusion
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.