(29 days)
Not Found
No
The summary describes a traditional medical device (injectable cement) and does not mention any AI or ML components or capabilities.
No
The device is a cement used for augmentation, attachment, stabilization, and reconstruction of middle ear structures. While it supports the function of a therapeutic process, the cement itself is a material rather than a device designed to deliver a therapeutic effect in the way a stimulator or drug delivery system would.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as being used for augmentation, coupling, attachment, stabilization, and reconstruction of middle ear structures. These are all therapeutic or reparative actions, not diagnostic ones. There is no mention of identifying, detecting, or monitoring medical conditions.
No
The device description clearly states it is a "Hydroxyapatite Cement. Powder and liquid mixed to form a paste for application. Injectable Cement. Calcium Phosphate material. Sterile." This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for surgical procedures related to the middle ear. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor medical conditions.
- Device Description: The description of a "Hydroxyapatite Cement" that is "injected" and forms a "paste for application" further supports its use as a surgical material within the body, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing, which are hallmarks of IVDs.
Therefore, the Stryker® Injectable Cement is a medical device used for surgical reconstruction and stabilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
Product codes (comma separated list FDA assigned to the subject device)
NEA, FMF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
060750
APR 1 9 2006
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Injectable Cement
General Information
| Proprietary Name: | Stryker® Injectable Cement |
|---|---|
| Common Name: | Hydroxyapatite Cement |
| Proposed Regulatory Class: | Class II |
| Device Classification: | NEA (21 CFR 872.3275) Cement, Ear, Nose and Throat |
| FMF (21 CFR 880.5860) Syringe, Piston | |
| Submitter: | Stryker® |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 877-534-2464 x 4226 | |
| Submitter's Registration #: | 8010177 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. Rutkoskie |
| Manager, Regulatory Affairs and Quality Assurance | |
| Phone: 877-534-2464 x 4226 | |
| Fax: 269-323-4215 | |
| Summary Preparation Date: | March 6, 2006 |
Intended Use
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
Substantial Equivalency Information
Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement, K043334 Stryker® HAC Rapid Set Cement, and K042516 Walter Lorenz Otomimix.
1
| | Stryker®
Injectable
Cement
(PENDING) | K060061
Stryker
Injectable
Cement | K043334
Stryker®
HAC
Rapid
Setting
Cement | K
042561
Walter
Lorenz
Otomimix |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|----------------------------------------------------------|---------------------------------------------|
| Intended Use: Stryker® Injectable Cement is
intended for use in the following: 1.
Augmentation or coupling of the middle ear
ossicles. 2. Attachment of the middle ear
ossicles to middle ear implants. 3.
Mechanical stabilization of the middle ear
prostheses. 4. Reconstruction of the
posterior canal wall. | √ | | | √ |
| Material: Calcium Phosphate | √ | √ | √ | √ |
| Sterility: Sterile | √ | √ | √ | √ |
| Operational Principle: Powder and liquid
mixed to form a paste for application | √ | √ | √ | √ |
| INJECTABLE Cement | √ | √ | | |
The primary predicate device, Stryker Injectable Cement (K060061), is identical in material formulation, physical properties, chemical composition and performance. All predicate devices share the same operational principles and are provided sterile.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service . . .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2006
Stryker® c/o Mr. Wade T. Rutkoskie 750 Trade Centre Way Kalamazoo, MI 49001
Re: K060750
Trade/Device Name: Stryker® Injectable Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Cement, Ear, Nose and Throat Regulatory Class: Class II Product Code: NEA Dated: March 24, 2006 Received: March 27, 2006
Dear Mr. Rutkoskie:
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. Wade T. Rutkoskie
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 10(t) marketed predicate device results in a classification for your device and thus, perfocts 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 (301) 827-8910. Also, please note (1) OFF C at 001), picc "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ahtain other general information on your responsibilities under the Act from the Division may onall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
MB Eychards. M
Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(K) Number (if known): K O 6 0 75-0
Device Name: Stryker® Injectable Cement
Indications for Use:
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle car ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.
Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Analshur
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
66075(
Page __ of