(73 days)
Not Found
No
The device description focuses on the mechanical components and materials of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implantable system intended for the management of segmental bone loss of the humerus in oncology patients, and also for shoulder girdle resections. These are therapeutic interventions designed to treat a medical condition (bone loss/resection due to tumors).
No
The device is described as an implantable system for managing segmental bone loss of the humerus, used to replace resected bone in oncology patients, and is not involved in diagnosis.
No
The device description clearly details physical components made of titanium alloy, such as stem sections, bone caps, and machine screws, which are implanted into the body. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to manage bone loss in the humerus due to tumors. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is a physical implant made of titanium, designed to be surgically inserted into the bone. This is characteristic of a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
In vitro diagnostics are tests performed on samples taken from the body to detect diseases, conditions, or infections. This device is a surgical implant used to replace or support bone structure.
N/A
Intended Use / Indications for Use
The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system (when used with the proximal bone cap described below) is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.
Product codes
77 HSD
Device Description
The Howmedica Humeral Intercalary System consists of a stem section with a body that may be attached to: 1) another stem section with body; or 2) a proximal bone cap. The stem section of the Humeral Intercalary System is fluted, and is available in diameters of 9mm and 11mm, with multiple body lengths. Both the stem segment and the proximal bone cap contain lap joints, which are joined by the use of machine screws that are available in diameters of 3 - 5 mm, and lengths of 15-20 mm.
The attachment of one stem segment to another stem segment is used when there is bone loss/resection of the mid-section of the humerus. The distal stem segment is cemented into the distal segment of the humerus, and the proximal portion is cemented into place in the proximal fragment of the humerus. The stem segments are joined by the use of the machine screws noted above.
If the proximal portion of the humerus is not present or has been resected, the bone cap segment is used proximally. There are suture holes in the bone cap to allow the passage of sutures to anchor the device proximally to the shoulder girdle (if this remains in place), or to the chest wall. The distal stem segment is cemented in place in the distal segment of the humerus. The bone cap is attached to the distal stem segment by the use of the screws noted above.
These components will be manufactured from titanium allov (Ti-6Al-4V) which conforms to ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, shoulder girdle
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
Physical and Finite Element Analysis testing of the device was presented.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
5 1999 FEB
510(k) Summary
Proprietary Name: Howmedica Humeral Intercalary System
Common Name: Modular Humeral Component
Classification Name and Reference: 21 CFR 888.3690 Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis
Proposed Regulatory Class: Class II
Device Product Code: 77 HSD OR (87)
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 11-24-98
The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system (when used with the proximal bone cap described below) is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.
The Howmedica Humeral Intercalary System consists of a stem section with a body that may be attached to: 1) another stem section with body; or 2) a proximal bone cap. The stem section of the Humeral Intercalary System is fluted, and is available in diameters of 9mm and 11mm, with multiple body lengths. Both the stem segment and the proximal bone cap contain lap joints, which are joined by the use of machine screws that are available in diameters of 3 - 5 mm, and lengths of 15-20 mm.
The attachment of one stem segment to another stem segment is used when there is bone loss/resection of the mid-section of the humerus. The distal stem segment is cemented into the distal segment of the humerus, and the proximal portion is cemented into place in the proximal fragment of the humerus. The stem segments are joined by the use of the machine screws noted above.
1
If the proximal portion of the humerus is not present or has been resected, the bone cap segment is used proximally. There are suture holes in the bone cap to allow the passage of sutures to anchor the device proximally to the shoulder girdle (if this remains in place), or to the chest wall. The distal stem segment is cemented in place in the distal segment of the humerus. The bone cap is attached to the distal stem segment by the use of the screws noted above.
These components will be manufactured from titanium allov (Ti-6Al-4V) which conforms to ASTM F-136.
The substantial equivalence of the Howmedica Humeral Intercalary System is based on an equivalence in intended use, material, design, and relative indications and contraindications to Howmedica's Proximal Humerus Replacement System (K954559); PMI's Proximal Humeral Segmental Replacement System (Biomet - K# unknown) and Metagen's Segmental Defect Replacement System (K980609).
Physical and Finite Element Analysis testing of the device was presented.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 5 1999
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K984202 Howmedica Humeral Intercalary System Trade Name: Requlatory Class: II Product Code: HSD Dated: November 24, 1998 November 24, 1998 Received:
Dear Mr. Dichiara:
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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ 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 requlations.
3
Page 2 - Mr. John F. Dichiara
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 requlation (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,
Neil R.F. Ogden for
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): k 984202
Device Name: Howmedica Humeral Intercalary System
Indications for Use: The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Prescription Use | X | OR | Over-The-Counter Use | |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
NRO
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K984202 |
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