(77 days)
Not Found
Not Found
No
The summary describes a physical, bioabsorbable screw for surgical fixation and contains no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as an "Interference Screw" intended for "tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction," which clearly indicates a medical purpose to treat or mitigate a condition.
No
The device is an interference screw used for fixation in ligament reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Bioabsorbable Interference Screw," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of tendon grafts in human cruciate ligament reconstruction. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bioabsorbable interference screw used for physical fixation.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease
- Using reagents or assays
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical implant used for mechanical support within the body.
N/A
Intended Use / Indications for Use
The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, femoral (for tendon graft fixation in human cruciate ligament reconstruction)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeons
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.
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
K030848 pg 191
JUN - 2, 2003 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Paul S. Lee
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Perforated Bioabsorbable Interference Screw |
| | Trade Name: (optional)
KSEA Perforated Bioabsorbable Interference Screw MegaFix™ |
Indication: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
Device Description: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.
Substantial Equivalence: The KSEA Perforated Bioabsorbable Interference Screw MegaFix" is substantially equivalent to the predicate devices since the basic features and intended use are similar. The minor differences between the KSEA Perforated Bioabsorbable Interference Screw and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device.
Signed:
YYY
Paul S. Lee Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's focus on health, human services, and well-being. The caduceus is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is simple, using a black and white color scheme.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2003
Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230
Re: K030848
Trade/Device Name: KSEA Perforated Bioabsorbable Interference Screw MegaFix™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 17, 2003 Received: March 17, 2003
Dear Mr. Lee:
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
2
Page 2 - Mr. Paul S. Lee
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 (301) 594-4639. 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 may be obtained 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 vours.
Sincerely yours,
Mark N. Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 03 0848
510(k) Number (if known): Not yet assigned
Device Name: KSEA Perforated Bioabsorbable Interference Screw MegaFix™
I idications for Use: The KSEA Perforated Bioabsorbable Interference Screw, MegaFix" i ; intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ---------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | Yes |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | No |
for Muh N. Milkenor
(Division Sign-Off)
드 바 등 등 문 및 문 로 바 높 공 뉴 뉴 로 바 로 드 뉴 버 트 트 님 용 트 브 스 트 바
(Optional Format 1-2-96)
Division of General, Restorative
and Neurological Devices
510(k) Number K030848
003