(196 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a physical orthopedic device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implant used for fixation in ACL reconstruction surgeries, which is a structural support function rather than a therapeutic one that directly treats a disease or condition.
No
Explanation: The device is an implant used for fixation in anterior cruciate ligament reconstruction surgeries, not for diagnosing medical conditions.
No
The device description clearly outlines a physical implant with two components (Base and Plate) made of materials, designed for surgical insertion and fixation in bone. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bone-tendon-bone anterior cruciate ligament reconstruction surgeries." This is a surgical procedure involving the physical repair of a ligament, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is an implant designed to be physically inserted into bone during surgery. It's a mechanical fixation device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect markers, or provide diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Innovasive Devices, Inc., ACL Clip-In Plate is indicated for use in the fixation of bonetendon-bone anterior cruciate ligament reconstruction surgeries.
Product codes (comma separated list FDA assigned to the subject device)
87 MBI
Device Description
The ACL Clip-In Plate device is a two component implant used in the fixation of bonetendon-bone grafts in anterior cruciate ligament reconstruction surgeries. The two device components are the Base and the Plate which are assembled together in the bone during the surgical procedure.
The ACL Clip-In Plate device consists of an outer threaded Base which is designed to be endoscopically delivered through a prepared tibio-femoral tunnel and manually inserted into the antero-lateral femur using a hex driver. The proximal end of the Base has a flexible wire assembled to it.
The Plate has two (proximal and distal) transverse spikes that are used to attach the bone end of the ligament graft on to it. The proximal end of the Plate has a circular groove equal to the diameter of the flexible wire in the Base. The flexible wire provides for a spring like property as the Plate passes through the Base. When the proximal end of the Plate engages with the flexible wire, it locks the Plate in place.
With regard to implant size, the Base comes in a 10mm diameter. The Plate is size specific and can be used only with the specified Base.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone-tendon-bone anterior cruciate ligament
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)
No performance standards exist at this time for the regulatory class under which the ACL Clip-In Plate is proposed for classification. However, in support of this submission, Innovasive Devices, Inc. has conducted the voluntary device testing in order to assess the effects of the new technological characteristics on the modes of failure of the device.
The effects of different materials on the modes of failure of the subject device were assessed in comparative testing with a selected predicate device.
The testing performed was:
- Strength of implant-graft-host bone construct .
a. Static
b. Dynamic
Post-test evaluation included:
- Host Bone- Implant Interface .
- Graft Implant Interface .
- Graft Incorporation .
With regard to testing, the subject device demonstrated equivalent or better performance compared to the selected predicate device in each of the three tests outlined above. With regard to post test evaluation, the subject device demonstrates equivalent or better performance compared to the selected predicate device in post dynamic test evaluations of the host bone-implant interface and the graft-implant interface. Provisions for graft incorporation are essentially identical between the subject and predicate devices, if not better due to the fact that bone-to-bone healing occurs faster than soft tissue-to- bone healing. Both the devices provide transverse support of the graft and all provide almost the same amount of graft-host bone surface area contact to facilitate graft incorporation.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
17150190 09.01 TAA OUL 139 1000 22414121 4 22 42 27 1 1 1 1
nit and and 12211668122008 11
2011 12 020
APR 2 4 1998
510 (K) SUMMARY
- Date of Summary Preparation 1 Jan. 26, 1998
- Submitter's Name & Address 2 Innovasive Devices, Inc. 734 Forest Street, Marlborough, MA 01752 508-460-8229 Telephone: 508-460-8997 Fax:
- Contact Person 3 MR. Eric Bannon Vice President, QA/RA
- Manufacturer's Contact Person 4 Mr. T. Wade Fallin Exec. Vice President Innovasive Devices, Inc. 180 South 600 West Logan, UT 84321 801-753-7675 Telephone: 801-753-7698 Fax:
- Proprietary Device Name 5 ACL Clip-In Plate
- Common Name б Endosteal Fixation Device
7 Classification Name
Smooth or Threaded Metallic Bone Fixation Fastener. Single/multiple component bone fixation appliances and accessories
- Classification Reference 8 21CFR 888.3030
- 9 Device Product Code 87 MBI
- Regulatory Class 10 Class II
1
11 Materials
The following material is used in the manufacturing of the Base and Plates. Ti-6Al-4V ELI per ASTM F-136. Nitinol Wire (Ni-Ti Alloy)
Indications for Use 12
Innovasive Devices, Inc., ACL Clip-In Plate is indicated for use in the fixation of bonetendon-bone anterior cruciate ligament reconstruction surgeries.
Description 13
Technological Characteristics
The ACL Clip-In Plate device is a two component implant used in the fixation of bonetendon-bone grafts in anterior cruciate ligament reconstruction surgeries. The two device components are the Base and the Plate which are assembled together in the bone during the surgical procedure.
The ACL Clip-In Plate device consists of an outer threaded Base which is designed to be endoscopically delivered through a prepared tibio-femoral tunnel and manually inserted into the antero-lateral femur using a hex driver. The proximal end of the Base has a flexible wire assembled to it.
The Plate has two (proximal and distal) transverse spikes that are used to attach the bone end of the ligament graft on to it. The proximal end of the Plate has a circular groove equal to the diameter of the flexible wire in the Base. The flexible wire provides for a spring like property as the Plate passes through the Base. When the proximal end of the Plate engages with the flexible wire, it locks the Plate in place.
With regard to implant size, the Base comes in a 10mm diameter. The Plate is size specific and can be used only with the specified Base.
14 Substantially Equivalent Predicate Devices
| Predicate Devices Identification | |||
|---|---|---|---|
| MANUFACTURER'S | |||
| NAME | DEVICE NAME | 510(K) DOCUMENT No. | 510(K) |
| CLEARED | |||
| Mitek Surgical | |||
| Products., | |||
| Norwood, MA | Mitek | ||
| Ligament | |||
| Anchor | K926270 | Yes |
TABLE Predicate Devices Identification
2
Substantial Equivalence ાર
01/20/90 - 09:00 - 14A 00. 100
15.1 Technological Characteristics
15.1.1 Similarities
- (a) The ACL Clip-In Plate device shares very similar technological characteristics with the predicate device. Both devices have:
... . . . . . . .
And And Andrew States of Same of
-
- a bone fixation element, and
-
- a linkage element that connects the graft to the bone fixation element.
15.1.2 Differences
- (a) The ACL Clip-In Plate uses different materials that the predicate device.
- (b) The linkage element is suture material, either regular suture tape, such as Mersilene Tape (Ethicon, New Brunswick, NJ) which is looped through the bone fixation element and the bone end of the graft for the predicate device. For the subject device it is a Plate with transverse pins for attaching the bone end of the graft and a proximal pin which locks into the Base.
15.2 Rationale for Differences
- (a) The subject device uses a well proven material which provides for greater strength and biocompatability.
- (b) The predicate device does not provide for a straight forward method for actaching bonetendon ligaments (e.g.: bone-patellar tendon-bone ligaments) to its linkage element. It may be used with the bone-tendon grafts when used with either suture tape (which would be the weak link of the construct). The subject device provides for a means to attach the bone end of the graft by providing transverse pins that may be passed through pre-drilled holes in the bone plug.
- (c) Another potential clinical advantage is afforded by the connection means between the bone fixation element and the linkage element. This connection provides an axial lock, but will allow for rotational movement. Thus, the surgeon can adjust graft position along the axis of the bone tunnel after the linkage element, with graft attached, is connected to the bone fixation element. This is accomplished by engaging the Clip-In removal tool on the distal end of the Plate and turning it to reposition the graft in a distal to inferior direction.
- (c) A further potential clinical advantage is the ability to disengage the linkage element from the bone fixation element without damaging the linkage element or the graft by use of a simple This may be an advantage in the event that the surgeon may need to removal punch. reconfigure the linkage-graft construction. This removal tool engages the proximal end of the assembled bone fixation element and linkage element, and provides release with a rotationally directed compression force. Also provided is a implant removal tool, which helps unthread the assembly (Base + Plate) via the tibio-femoral tunnel.
3
16 Performance Data
No performance standards exist at this time for the regulatory class under which the ACL Clip-In Plate is proposed for classification. However, in support of this submission, Innovasive Devices, Inc. has conducted the voluntary device testing in order to assess the effects of the new technological characteristics on the modes of failure of the device.
The effects of different materials on the modes of failure of the subject device were assessed in comparative testing with a selected predicate device.
The testing performed was:
- Strength of implant-graft-host bone construct .
- a. Static
- b. Dynamic
Post-test evaluation included:
- Host Bone- Implant Interface .
- Graft Implant Interface .
- Graft Incorporation .
With regard to testing, the subject device demonstrated equivalent or better performance compared to the selected predicate device in each of the three tests outlined above. With regard to post test evaluation, the subject device demonstrates equivalent or better performance compared to the selected predicate device in post dynamic test evaluations of the host bone-implant interface and the graft-implant interface. Provisions for graft incorporation are essentially identical between the subject and predicate devices, if not better due to the fact that bone-to-bone healing occurs faster than soft tissue-to- bone healing. Both the devices provide transverse support of the graft and all provide almost the same amount of graft-host bone surface area contact to facilitate graft incorporation.
Conclusion 17
Based on the design concept, use of standard material, feature comparisons to a selected predicate device, the device and predicate device testing, Innovasive Devices, Inc. believes that sufficient evidence exists to conclude that the ACL Clip-In Plate Device is substantially equivalent to existing legally marketed endosteal fixation devices.
4
Image /page/4/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 1998
Mr. Eric Bannon Vice President of Regulatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
Re: K973874 ACL Clip-In Plate Trade Name: Requlatory Class: II Product Code: MBI Dated: January 23, 1998 Received: January 27, 1998
Dear Mr. Bannon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈਂ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. Eric Bannon
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cella M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
6
. .
INDICATIONS FOR USE 3.
Statement of Indications for Use 3.1
Statement of Indications for Use
Innovasive Devices, Inc. (IDI) - ACL Clip-In Plate is indicated for use in the fixation of Innovasive Devices, mo. (122) - 1102 - 1102 - 1102 - 1102 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 -
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of General Restorative Device 510(k) Number
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