(427 days)
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No
The document describes a mechanical surgical staple and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is described as a medical staple used for fixation in various bone surgeries (osteotomies, arthrodeses), which are therapeutic procedures aimed at correcting or treating medical conditions.
No
The device is described as a fixation staple used in orthopedic surgeries to fix bones, not to diagnose conditions.
No
The device description clearly states it is a physical, single-patient use device made of surgical grade stainless steel, designed for bone fixation. It undergoes physical performance testing (bending, fatigue, pull-out) and biocompatibility testing, which are characteristic of hardware devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Mediscope Asymmetrical Compression Staple is a surgical implant made of stainless steel. Its intended use is for fixation of bones during surgical procedures like osteotomies and arthrodeses. It is physically implanted into the body to stabilize bone structures.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. It is a mechanical device used to hold bones together.
Therefore, based on the provided information, the Mediscope Asymmetrical Compression Staple clearly falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position.
The design features of the Mediscope Compression Staple are summa-rized below:
- Manufactured from nickel-free stainless steel .
- 5 sizes .
- Barbs to prevent back out .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
forefoot, midfoot, hindfoot, metatarsophalangeal, metatarsocuneiform joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalency of the Mediscope Asymmetrical Compression Staple and the Wright Medical Charlotte Staple was proven through testing as outlined in ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples). The following is a list of the tests conducted used to compare the two devices: (1) Elastic Static Bending of Metallic Bone Staples; (2) Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples; and (3) Pull-Out Fixation Strength of Metallic Bone Staples.
Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Wright Medical Compression Staple and Simple Staple (K043059)
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.
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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).
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENES
Date of Submission
Official Contact / Address of Manufacturing facility
August 9, 2010
Daniel Helme Chief Operating Officer Mediscope Manufacturing Inc. 2832 NW 22nd Terrace Pompano Beach, FL 33069
Phone: 954-975-9997 Fax: 954-975-0775 dhelme@mediscope-mfg.com
| Trade Name | Mediscope Asymmetrical Compression Staple and Accessories |
|---|---|
| Common/Usual Name | Asymmetrical Compression Staple |
| Device Classification Name | Staple, Fixation, Bone |
| Classification Reference | 21 CFR 888.3030 |
| Classification | Class II |
| Appropriate Classification Panel | Orthopedic |
| Product Code | JDR |
| Predicate Devices | The device is substantially equivalent to: |
| Wright Medical Compression Staple and Simple Staple (K043059) |
Reason for submission
New device
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1
Device Description
The Mediscope Compression Staple is a single patient use device made of surgical grade The Medisope Oompression Stapie is cross the fusion site of two bones from the adiacent position.
The design features of the Mediscope Compression Staple are summarized below:
- Manufactured from nickel-free stainless steel .
- 5 sizes .
- Barbs to prevent back out .
Indications for Use
The Mediscope Asymmetrical Compression Staple is intended to be used for fixation such as: r in wedisoope noymined. Ostedtical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus
treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Summary of Testing and Conclusion
The Mediscope Asymmetrical Compression Staple has the following similarities to the previously cleared predicate device:
- Same operating principle. ם
- Same technology. ロ
- O Same intended use.
Substantial equivalency of the Mediscope Asymmetrical Compression Staple and the Wright Medical Charlotte Staple was proven through testing as outlined in ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples). The following is a list of the tests conducted used to compare the two devices: (1) Elastic Static Bending of Metallic Bone Staples; (2) Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples; and (3) Pull-Out Fixation Strength of Metallic Bone Staples.
Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): "Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing".
(End of Tab.)
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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 stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mediscope Manufacturing, Inc. % Dr. Diane Sudduth Senior RA & OA Consultant 8282 Shadow Wood Boulevard Pompano Beach, Florida 33069
OCT 2 4 2011
Rc: K102387
Trade/Device Name: Mediscope Compression Staple and Accessories Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: September 16, 2011 Received: September 19, 2011
Dear Dr. Sudduth:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Dr. Diane Sudduth
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/defaul/htm.
Sincerely yours,
Fan
Mark N. Melkefo Melkerson
Director
On
Division of Surgical, Orthopedic
and Restorative Devices
and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K102387
Device Name: Mediscope Asymmetrical Compression Staple and Accessories
The Mediscope Asymmetrical Compression Staple is intended to be used for The Mediooope Acymholinshrodesis, mono or bi-cortical osteotomies in the fixaton Suon ao. Lior ano alangeal arthrodesis, Akin osteotomy, midfoot and foreloot, first motatures, fixation of osteotomies for hallux valgus hindloot arthrouses of Colon), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Prescription Use ____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Rines for MRM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K902387
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