(45 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing of the implant.
No
The device is an implantable interbody fusion system designed to aid in spinal fusion, which is a structural support and stabilization treatment rather than a direct therapeutic intervention.
No
The device is an implantable medical device used for intervertebral body fusion procedures. It is used in the treatment of degenerative disc disease, not for diagnosing it. The mention of "radiographic studies" refers to the confirmed degeneration of the disc, which is presumably a diagnostic step taken prior to the use of this device, not a function of the device itself.
No
The device description clearly outlines physical implants made of PEEK with tantalum markers, and mentions instruments for implantation. This indicates a hardware-based medical device, not software-only.
Based on the provided information, the Hubble II Lumbar Interbody Fusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Hubble II Function: The Hubble II Lumbar Interbody Fusion System is an implantable medical device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used in the body, not a device used to test samples from the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test.
- Device Description: The description details the physical components of the implant and instruments, not reagents or equipment for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the Hubble II Lumbar Interbody Fusion System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Hubble II Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be sketally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Hubble II Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
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
No clinical or animal studies were performed.
Description of the test set, sample size, data source, and annotation protocol
No clinical or animal studies were performed.
Summary of Performance Studies
The Hubble II Lumbar Interbody Fusion System was evaluated to demonstrate equivalence to the predicate device. The predicate was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear per ASTM F2077-14, subsidence per ASTM F2267-04 and expulsion per a recognized industry standard. As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2016
Orbbo Surgical, LLC % Tamala Wampler Regulatory and Ouality Consultant Novus Management Group, LLC. 6686 Dimmick Road West Chester, Ohio 45069
Re: K163180 Trade/Device Name: Hubble II Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 25, 2016 Received: November 14, 2016
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,
Caroline Rhim -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 ) | K163180 |
|---|---|
| Device Name | Hubble II |
Indications for Use (Describe)
The Hubble II Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be sketally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D) 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)
Page 1 of 1
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 Drug 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 respond to, a collection of information unless it displays a currently valid OMB number."
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510(K) SUMMARY
| Submitter's Name: | Orbbo Surgical, LLC |
|---|---|
| Submitter's Address: | 555 W. 5th Street, 35th Floor |
| Los Angeles, California 90013 | |
| Submitter's Telephone: | 213-282-3662 |
| Company Contact Person: | Eric Garofano |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group, LLC. | |
| 513-593-4944 | |
| Date Summary was Prepared: | October 25th, 2016 |
| Trade or Proprietary Name: | Hubble II |
| Common or Usual Name: | Intervertebral body fusion device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Hubble II Lumbar Interbody Fusion System consist of 3 designs, PLIF & PLIF BS, TLIF and OLIF. The PLIF and TLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F560 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.
INDICATIONS FOR USE
The Hubble II Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Hubble II System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Hubble II System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
PREDICATES
Hubble II is made PEEK-Optima LT1. The subject and predicate device have identical technological characteristics. The Twin Peaks, the primary predicate is identical to the Hubble II with the exception of it being marketed by a different company under a different product name. Specifically, the following characteristics are identical between the subject and secondary predicates:
4
- Indications for Use (identical) ●
- Materials of manufacture (identical) ●
- . Structural support mechanism (identical)
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or Model
Name | Manufacturer | Type |
|----------------|---------------------------------------|--------------|---------|
| K152355 | Twin Peaks | Spineway | Primary |
PERFORMANCE TESTING
The Hubble II Lumbar Interbody Fusion System was evaluated to demonstrate equivalence to the predicate device. The predicate was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, static and dynamic compression shear per ASTM F2077-14, subsidence per ASTM F2267-04 and expulsion per a recognized industry standard. As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed.
CONCLUSION
Orbbo concludes that the Hubble II Lumbar Interbody Fusion System raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices.