(137 days)
Not Found
No
The summary describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The Kepler II is indicated for use in patients with degenerative disc disease (DDD) and requires an implant via an open, anterior approach. It is intended to treat a medical condition.
No
This device is a cervical cage designed for spinal fusion, not for diagnosing medical conditions. Its purpose is to treat degenerative disc disease by providing structural support and facilitating fusion, rather than by identifying or characterizing a disease.
No
The device description clearly states it is a cervical spinal interbody fusion device made of PEEK polymer with tantalum markers, and includes instrumentation for implantation. This indicates a physical implant and surgical tools, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Kepler II is a cervical cage for spinal fusion in patients with degenerative disc disease. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a physical implant made of PEEK polymer and tantalum markers, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while the Kepler II is a therapeutic device implanted directly into the body.
N/A
Intended Use / Indications for Use
The Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Kepler II Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Kepler II Cervical Cage is manufactured from PEEK-OPTIMA LT1 polymer and contains tantalum radiopaque markers. The Kepler II Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
Indicated Patient Age Range
Skeletally mature patients
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)
Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear and Dynamic Torsion per ASTM F2077-14, Subsidence per ASTM F2267-04 (reapproved 2011) and Expulsion testing per a recognized industry norm were met. No clinical testing was performed. Bacterial endotoxin testing per USP34 and NF 29. Material-mediated pyrogenicity per ISO 10993-11 (2006) and ASTM F750-87 (2007).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Orbbo Surgical, LLC % Tamala Wampler Regulatory and Ouality Consultant Novus Management Group, LLC 6686 Dimmick Road West Chester, Ohio 45069
Re: K163265
Trade/Device Name: Kepler II Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: March 3, 2017 Received: March 7, 2017
Dear Ms. Wampler:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K163265 Device Name Kepler II
Indications for Use (Describe)
The Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of nonoperative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| FOR FDA USE ONLY |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
PSC Publishing Services (301) 443-6740 EF
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Submitter's Name: | Orbbo, LLC. (Orbbo Surgical, LLC.) |
|---|---|
| Submitter's Address: | 555 W. 5th Street, 35th Floor |
| Los Angeles, CA 90013 | |
| Submitter's Telephone: | (800) 942-1880 |
| Company Contact Person: | Eric Garofano |
| CEO | |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group, LLC. | |
| 513-593-4944 | |
| Date Summary was Prepared: | 11/13/2016 |
| Trade or Proprietary Name: | Kepler II |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Kepler II Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Kepler II Cervical Cage is manufactured from PEEK-OPTIMA LT1 polymer and contains tantalum radiopaque markers. The Kepler II Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
INDICATIONS FOR USE
The Kepler II is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Kepler II implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Kepler II Cervical Cage is to be used with supplemental fixation.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The subject device is substantially equivalent to the predicates. The subject device is equivalent to the predicates in regards to technological characteristics including design, indications for use, intended use, material composition, and function.
4
PREDICATES
Kepler II is made PEEK-OPTIMA LT1. The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use (identical)
- Materials of manufacture (identical) ●
- Structural support mechanism (identical) ●
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or
Name | Manufacturer | Type |
|----------------|---------------------------------|---------------|------------|
| K112801 | Ayers Rock | Qualgenix | Primary |
| K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | Additional |
PERFORMANCE TESTING
Orbbo, LLC. Kepler II was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear and Dynamic Torsion per ASTM F2077-14, Subsidence per ASTM F2267-04 (reapproved 2011) and Expulsion testing per a recognized industry norm were met. No clinical testing was performed. Bacterial endotoxin testing per USP34 and NF 29. Material-mediated pyrogenicity per ISO 10993-11 (2006) and ASTM F750-87 (2007).
CONCLUSION
The Kepler II has been tested per ASTM F2077 in Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion and ASTM F2267 Subsidence as well as expulsion testing and were considered substantially equivalent to other legally marketed devices. The subject Kepler II has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The overall technology characteristics lead to the conclusion that the Kepler II is substantially equivalent to the predicate devices.