(77 days)
Not Found
No
The device description and the absence of any mention of AI, ML, image processing, training/test sets, or performance metrics related to algorithmic analysis strongly indicate that this is a purely mechanical implant device.
No
The device is an implant used for anchoring soft tissue to bone, which is a structural and mechanical function, not a therapeutic one. Therapeutic devices typically involve treating a disease, restoring function through biological or pharmacological means, or providing diagnoses related to physiological states. This device serves as a fixture in a repair process.
No.
The device description indicates it is an implantable suture anchor used for surgery to repair soft tissue to bone, not for diagnosing conditions.
No
The device description clearly states it is a "single use implantable device" manufactured from titanium, indicating it is a physical hardware 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 "anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair." This describes a surgical implant used in vivo (within the body) to physically attach tissues.
- Device Description: The description details a "single use implantable device" made of titanium and used with sutures. This further confirms its nature as a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided description contains none of these elements.
Therefore, the Acumed Suture Anchor is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
This device is intended for anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.
Product codes
MBI
Device Description
The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle, rotator cuff
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)
Not Found
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
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
acumen®
Quality Orthopaedic Instruments and Implants
Appendix F - 510 (k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed. Information regarding labeling has been provided.
Predicate devices that are substantially equivalent to the Acumed Suture Anchor are the Mitek GII Anchor and SuperAnchor, the Linvatec Revo, and the Zimmer Statak. All the devices mentioned above have the same indications and are manufactured from titanium. The design of the Acumed Suture Anchor is screw based and is similar to the Linvatec Revo and the Zimmer Statak. The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques. Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above.
Acumed, Inc. � 10950 S.W. 50 € Beaverton, OR 97005 � (503) 627-9957 ◆ Fax (503) 520-9618 C1998, Acumed, Inc. Appendix F
ടലമപ 00. 341 SS STREET & 1388558825355 14:44 0002/70/10
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Ms. Shari Jeffers Regulatory Affairs Manager Acumed. Inc. 10950 S.W. 5th Street Suite 170 Beaverton, Oregon 97005
Re: K993657 Trade Name: Acumed Suture Anchor Regulatory Class: II Product Code: MBI Dated: October 18, 1999 Received: October 28, 1999
Dear Ms. Shari Jeffers:
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, Drug, and Cosmetic Act (Act). 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.
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. A 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 regulation (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 action. In addition. FDA may publish further announcements 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.
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
2
Page 2 - Ms. Shari Jeffers
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) 594-4595. 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,
Russell W. Rogers
& James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_ K 993657
Device Name: Acumed Suture Anchor
Indications For Use:
This device is intended foranchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Plunell Sawyer teriz.
Division Sign-Off Division of General Restorative Devices 510(k) Number
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)