(27 days)
Not Found
No
The 510(k) summary describes a mechanical implant for elbow arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use in reducing or relieving pain and improving elbow function due to degenerative joint diseases, traumatic arthritis, inflammatory degenerative joint disease, functional deformity, and fractures, which are therapeutic purposes.
No
The device is an implant for joint replacement in the elbow, intended for treating pain and improving function, not for diagnosing conditions.
No
The device description clearly states it is an "implant" and describes its use in surgical procedures, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description and Intended Use: The provided text describes a surgical implant (SBI Radio-Capitellar implant) used to treat conditions within the elbow joint. It is a physical device implanted into the body to restore function and reduce pain.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing specimens from the human body. The device's function is mechanical and structural within the joint.
Therefore, the SBI Radio-Capitellar implant falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBI Lateral Assembly Radio-Capitellar implant is intended for cemented use only.
Product codes
JDB
Device Description
The SBI Lateral Radio Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
elbow
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)
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.
Not Found
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.
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
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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510(k) Summary
| Manufacturer: | rms Company
8600 Evergreen Boulevard
Minneapolis, MN 55433
763-786-1520 - Office
763-783-5073
FEB 2 1 2007 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
1711 South Pennsylvania Avenue
Morrisville, PA 19067 |
| Proprietary Name: | SBI Lateral Radio Capitellum |
| Classification name: | Class II, 888. 3160 - Prosthesis, Elbow, Semi-Constrained,
Cemented |
| Common/Usual Name: | Elbow joint metal/polymer semi-constrained cemented
prosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
Lateral Radio Capitellum to be substantially equivalent to
other legally marketed devices. |
| Device Description: | The SBI Lateral Radio Capitellar Implant provides an
alternative to hemi-arthroplasty of the proximal radial head.
The implant is used for the treatment of degenerative joint
disorders of the radio-capitellar joint allowing activities of
daily living to be performed with no or significantly
reduced pain. The radio-capitellar implant is designed to
be used with the radial stem components of the rHead and
rHead Recon stem implants cleared for market under
510(k) K011819 and K023604 respectively. |
| Intended Use: | The SBI Radio-Capitellar implant is indicated for use in the
elbow for reduction or relief of pain and/or improved elbow
function in skeletally mature patients with the following
conditions: 1) non-inflammatory degenerative joint disease
including osteo-arthritis or traumatic arthritis; 2)
inflammatory degenerative joint disease including
rheumatoid arthritis; 3) correction of functional deformity;
4) revision procedures where other treatments and devices
have failed; and 5) treatment of fractures that are
unmanageable using other techniques. The SBI Lateral |
:
:
:
1
K070236 2/2
Assembly Radio-Capitellar implant is intended for cemented use only.
Material:
ASTM F-648: Ultra-High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM F-1537: Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants. ASTM F1580: Titanium and Titanium-6Aluminum-4Vanadium Alloy Powders and Coatings of Surgical Implants.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations % Mr. Robert Hoehn Regulatory Associate Musculoskeletal Clinical Regulatory Advisers 505 Park Avenue, 14th Floor New York, NY 10022
K070236 Trade/Device Name: SBI Lateral Radio Capitellum Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDB Dated: January 15, 2007 Received: January 25, 2007
FEB 2 1 2007
Dear Mr. Hoehn:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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 - Mr. Robert Hoehn
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchum
tor
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K070236
Device Name: SBI Lateral rHead
Indications For Use:
The Small Bone Innovations' (SBi) Lateral Assembly Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
The SBi Lateral Assembly Radio-Capitellar implant is intended for cemented use only.
1/1
Prescription Use V (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)
Page 1 of 1
Barbara Becker
(Division Sign-Off) (Division Sign of General, Restorative, ological Devices
510(k) Number K070236
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