(90 days)
No
The document describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for intervertebral body fusion of the lumbar spine, which is a medical treatment.
No
The Helena System is an intervertebral body fusion device and is intended for treatment, not diagnosis. It is used to facilitate fusion of the lumbar spine, which is a therapeutic intervention.
No
The device description explicitly states that the Helena System consists of physical components made of PEEK and tantalum, and is implanted using stainless steel instruments. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Helena System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for intervertebral body fusion of the lumbar spine. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is described as an implantable interbody fusion device made of PEEK and tantalum markers, used with surgical instruments. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the Helena System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of: Lumbar interbody fusion device(s), which may be implanted - bi-laterally via a posterior (PLIF) approach; - as a single device via a transforaminal (TLIF) approach - as a single device via an anterior (ALIF) approach; or The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following non-clinical tests were conducted: - Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 - Subsidence testing, conducted in accordance with ASTM F2267-04 - Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Helena System is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
P950019, P960025, K090064, K090376, P950002
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
K110177
Page 1 of 2
510(k) Summary Royal Oak Medical Devices Helena System
APR 2 1 2011
Premarket Notification
SUBMITTED BY
Royal Oak Medical Devices 39533 Woodward Avenue Bloomfield Hills, MI 48304
ESTABLISHMENT REGISTRATION NUMBER
Pending
OWNER/OPERATOR NUMBER
Pending
CONTACT PERSON
Matthew Kroll Vice President of Technical Services Royal Oak Medical Devices Phone: 248-628-2830 Fax: 248-969-8263
Intervertebral Body Fusion Device
888.3080 (Product Code: MAX)
SUBMISSION PREPARED BY
Lisa Peterson QA Consulting, Inc. Phone: 512-507-0746
March 17, 2011
Helena System
Class II
DATE PREPARED
CLASSIFICATION NAME
DEVICE CLASS
REGULATION NUMBER
COMMON NAME
PROPRIETARY NAME
IDENTIFICATION OF PREDICATE DEVICE(S)
Predicate devices include various cleared interbody fusion systems:
Intervertebral Fusion Device with Bone Graft, Lumbar
- RAY® Threaded Fusion Cage (P950019) -
- -Lumbar I/F Cage (P960025)
- -Eminent Spine System (K090064)
- SpineSmith Cynch System (K090376) -
- BAK Vista (P950002) -
1
KII017
page 2 of 2
DEVICE DESCRIPTION
The Helena System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:
Lumbar interbody fusion device(s), which may be implanted
- bi-laterally via a posterior (PLIF) approach;
- as a single device via a transforaminal (TLIF) approach -
- as a single device via an anterior (ALIF) approach; or
The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Helena System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
INDICATIONS
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this premarket notification is to obtain clearance to market the Helena System. The Helena System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.
The Helena System implant components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:
- Intended for use at either one level or two contiquous levels from L2-S1 for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s).
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 ।
- Subsidence testing, conducted in accordance with ASTM F2267-04 ।
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 -
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Helena System is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a single snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 .
Royal Oak Medical Devices % Mr. Matthew Kroll Vice President of Technical Services 39533 Woodward Avenue Bloomfield Hills, Michigan 48304
APR 2 1 2011
Re: K110177
Trade/Device Name: Helena System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 21, 2011 Received: March 23, 2011
Dear Mr. Kroll:
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
3
Page 2 -- Mr. Matthew Kroll
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hing B. Rha
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K110177 510(k) Number (if known):
Device Name: Helena System
Indications for Use:
The Helena System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiquous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI10177 510(k) Number_________________________________________________________________________________________________________________________________________________________________
39533 Woodward Avenue Bloomfield Hills, Michigan 48304 Royal Oak Medical Devices
Phone: 248-628-2830 Fax: 248-969-8263