(86 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a polymer staple, with no mention of AI or ML.
Yes
The RMB Staple is used for fixation of soft tissue grafts during rotator cuff repair, which is a therapeutic intervention aimed at repairing damaged tissue.
No
Explanation: The device description and intended use clearly state that the RMB Staple is used for fixation of soft tissue grafts during rotator cuff repair, indicating a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "sterile, single use polymer strap with cleat tips" made of PEEK material, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue grafts during rotator cuff repair." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "polymer strap with cleat tips" used with a "manual staple driver." This is a physical implant and surgical tool, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The RMB Staple is a surgical implant used to physically secure tissue during a surgical procedure. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is composed of PEEK material. The RMB Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical. (Note: Rotation Medical's orthopedic manual staple driver is a Class I exempt device pursuant to 21 CFR 888.4540 and is not the subject of this submission).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
RMB Staple has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility and substantial equivalence to the predicates, including: cytotoxicity, sensitization, intracutaneous reactivity, toxicity, and animal testing with histology. In addition, in vivo and in vitro strength and retention were also assessed.
The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices.
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.
Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K093845; SwiveLock Anchors, K101823
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
Image /page/0/Picture/0 description: The image shows the logo for Rotation Medical. The logo consists of a series of circles arranged in a semi-circular pattern, with some of the circles filled in with a darker color. Below the circles is the word "rotation" in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font. To the right of the logo is the number K131633.
K131635 Page 1/2
AUG 2 9 2013
510(k) Summary
Applicant Information
| Applicant Name: | Rotation Medical, Inc. |
|---|---|
| Applicant Address: | 15350 25th Avenue North, Suite 100 |
| Plymouth, MN 55447 | |
| Telephone: | 763-746-7521 |
| Fax: | 763-746-7501 |
| Contact Person: | Gail Schroeder |
| Director, Quality Assurance and Operations | |
| Date Prepared: | August 27, 2013 |
Name of Device
Device Common Name: Device Trade Name: Device Classification Name: Nondegradable soft tissue to bone fixation staple Rotation Medical Bone Staple (RMB Staple) Bone Fixation Fastener 888.3040 Class II MBI
Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s):
Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device, K093845; Ethicon, Inc.
SwiveLock Anchors, K101823 Arthrex, Inc.
Description of the Device
The RMB Staple is a sterile, single use polymer strap with cleat tips. RMB Staple is composed of PEEK material. The RMB Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical. (Note: Rotation Medical's orthopedic manual staple driver is a Class I exempt device pursuant to 21 CFR 888.4540 and is not the subject of this submission).
1
Image /page/1/Picture/0 description: The image shows the logo for Rotation Medical, along with the text "K131635 Page 2/2". The logo consists of the word "rotation" in a bold, sans-serif font, with the word "MEDICAL" underneath in a smaller font. Above the logo is a circular design made up of several circles, some of which are filled in with different shades. The text "K131635 Page 2/2" is located to the right of the circular design.
intended Use
The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.
Summary/Comparison of Technical Characteristics
The RMB Staple and the predicate device, Ethicon Securestrap™, have similar indications for use and physical design. Both devices are indicated for the fixation of prosthetic material, and are comprised of a polymer strap with barbed ends. The Securestrap™ is optimized for soft tissue fixation, while the RMB Staple is optimized for fixation to bone. The RMB Staple and the predicate device, SwiveLock Anchor, are made of the same material, PEEK, and are used similarly to aid in the management of tendon injuries by affixing a prosthetic material to bone. The RMB Staple directly affixes the prosthetic material to bone, while the predicate SwiveLock indirectly affixes the prosthetic material by proving an anchor point for sutures which have been sewn to/through the prosthetic material.
RMB Staple has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility and substantial equivalence to the predicates, including: cytotoxicity, sensitization, intracutaneous reactivity, toxicity, and animal testing with histology. In addition, in vivo and in vitro strength and retention were also assessed.
Conclusion
The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. The results of the in vitro product characterization studies, bench testing and in vitro and in vivo biocompatibility studies, as well as the animal efficacy study demonstrate that the RMB Staple is safe and substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 29, 2013
Rotation Medical, Inc. Gail Schroeder Director, Quality Assurance and Operations 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447
Re: K131635
Trade/Device Name: Rotation Medical Bone Staple (RMS Staple) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 23, 2013 Received: July 24, 2013
Dear Ms. Schroeder:
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
3
Page 2 - Gail Schroeder
CFR Part 807); labeling (21 CFR Part 801); medical device 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/MedicalDevices/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/Medica|Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Confidential Rotation Medical, Inc.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Rotation Medical Bone Staple (RMB Staple)
Indications for Use:
The RMB Staple is indicated for fixation of soft tissue grafts during rotator cuff repair.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131635
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