(217 days)
No
The 510(k) summary describes a physical implant (cervical cage) and associated instrumentation, with no mention of software, algorithms, or AI/ML terms. The performance studies focus on mechanical properties and equivalence to predicate devices.
Yes
The device is indicated for treating degenerative disc disease (DDD) and accompanying radicular symptoms, which are medical conditions, and it is implanted to facilitate spinal fusion.
No
The device is an implantable cervical cage used for treating degenerative disc disease, not for diagnosing it.
No
The device description clearly states it consists of physical implants (cervical spinal interbody fusion devices made from PEEK polymer) and instrumentation for implantation, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Qualgenix Ayers Rock Cervical Cage is an implantable device designed to be surgically placed in the cervical spine to facilitate fusion. It is a physical device used within the body.
- Intended Use: The intended use is for surgical implantation to treat degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The provided information clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Qualgenix Ayers Rock Cervical Cage 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 Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.
Product codes
ODP
Device Description
The Ayers Rock Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical Cage is manufactured from PEEK OPTIMA LT1 polymer. The Ayers Rock 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
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)
Preclinical testing has been performed per ASTM F2077 (static compression, compression-shear, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing) indicating that the Ayers Rock Cervical Cage is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAY - 1 2012
510(k) Summary
:
| Manufacturer: | Qualgenix LLC
1 Jack's Hill Road (Unit 3E)
Oxford, CT 06478
(203) 982 – 4239 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Ayers Rock Cervical Cage |
| Contact: | Richard Deslauriers, M.D.
CEO |
| Date Prepared: | September 21, 2011 |
| Classification: | §888.3080; Intervertebral body fusion device |
| Class: | II |
| Product Code: | ODP |
| Indications For Use: | The Qualgenix Ayers Rock Cervical Cage 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 Qualgenix
Ayers Rock Cervical Cage implants are to be used with
autogenous bone graft and implanted via an open, anterior
approach. The Qualgenix Ayers Rock Cervical Cage is to be
used with supplemental fixation. |
| Device Description: | The Ayers Rock Cervical Cage consists of cervical spinal
interbody fusion devices as well as instrumentation designed
specifically for the implantation of these devices. The Ayers
Rock Cervical Cage is manufactured from PEEK OPTIMA
LT1 polymer. The Ayers Rock Cervical Cage is for single
level anterior spinal use from the C2-C3 to C7-T1 disc levels. |
| Predicate Device(s): | The Ayers Rock Cervical Cage was shown to be
substantially equivalent to previously cleared devices and
has the same indications for use, design, and function.
Predicate devices include the LDR Spine MC+ (K080588)
and SpineArt Tryptik (K091873). |
1
Performance Standards: Preclinical testing has been performed per ASTM F2077 (static compression, compression-shear, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing) indicating that the Ayers Rock Cervical Cage is substantially equivalent to predicate devices.
Conclusion: Comparisons of device indications, intended use, design, and performance were made to predicate devices in order to determine substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Qualgenix LLC % Richard Deslauriers, M.D. CEO 1 Jack's Hill Road (Unit 3E) Oxford, Connecticut 06478
MAY - 1 2012
Re: K112801
Trade/Device Name: Ayers Rock Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: April 3, 2012 Received: April 4, 2012
Dear Dr. Deslauriers:
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 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.
3
Page 2 - Richard Deslauriers, M.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/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/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 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,
Sincerely yours,
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
K-11280 510(k) Number (if known):
Device Name: Qualgenix Ayers Rock Cervical Cage
The Qualgenix Ayers Rock Cervical Cage 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 Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.
Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIL2801 510(k) Number_