Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Device Description

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device modification, specifically the "Astra Tech Implant System, New Component." However, it does not contain information about acceptance criteria, the study that proves device meets acceptance criteria, detailed performance data, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission discussing the device's administrative information, intended use, description, and equivalence to a predicate device. It explicitly states that the modification "has the same intended use, uses the same operating principle, incorporates the same basic design, and is packaged using the same materials and processes" as the unmodified predicate device. This implies that the modification is considered substantially equivalent based on these similarities, rather than requiring a new, comprehensive performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Number of experts or their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance data.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not present in the provided 510(k) summary. The 510(k) process for device modifications often focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, extensive performance studies with detailed acceptance criteria if the changes are minor and do not alter the fundamental safety or effectiveness of the device.

Summary

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KC72624

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510(k) Summary

Astra Tech Implant System, New Component

510(k) Summary

OCT 1 2007

Astra Tech AB Special 510(k): Device Modification

Astra Tech Implant System, New Component

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 Telephone: +46 31 776 30 00 Fax: +46 31 776 30 10

Official Contact:

Representative/Consultant:

Christina Lewing

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone 1 (858) 792-1235 Fax 1 (858) 792-1236 Email: Ischulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name:

Product Code: Classification Panel: Reviewing Branch:

Astra Tech Implant System, New Component Endosseous dental implant abutment Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II NHA Dental Products Dental Devices

INTENDED USE

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K072624

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510(k) Summary

Astra Tech Implant System, New Component

DEVICE DESCRIPTION

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

EQUIVALENCE TO MARKETED PRODUCT

The modified Astra Tech Implant System has the following similarities to the unmodified predicate Astra Tech Implant System:

· has the same intended use,
· uses the same operating principle,
· incorporates the same basic design, and
· is packaged using the same materials and processes.

In summary, the modification to the Astra Tech Implant System described in this submission is, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Astra Tech AB C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, L.L.C. 11234 El Camino Real, Suite 200 San Diego, California 92130

OCT 1 2007

Re: K072624

Trade/Device Name: Astra Tech Implant System, New Component Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 13, 2007 Received: September 17, 2007

Dear Ms. Schulz:

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.

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Page 2 - Ms. Schulz

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Syrite Y. Michael Ows

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K072624

1071

Special 510(k): Device Modification

Astra Tech Implant System, New Component

Indications for Use

510(k) Number (if known):

Device Name:

Astra Tech Implant System, New Component

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Page 1 of _______
Infection Control, Dental Devices

510(k) Number:	K072624
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Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)