(77 days)
No
The summary describes a set of bone implants and instruments for fracture fixation and reconstruction. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on mechanical strength, not algorithmic performance.
No.
A therapeutic device is typically involved in the treatment or palliation of a disease or condition. This device is for "internal fixation of fractures and reconstruction of bones," which is a reconstructive and supportive function, not directly therapeutic in the sense of treating an ongoing disease process or palliation.
No
The device is intended for internal fixation of fractures and bone reconstruction, which is a therapeutic purpose, not diagnostic.
No
The device description explicitly lists physical components such as titanium plates and screws, which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Flower Small and Medium Implants set is used for internal fixation of fractures and reconstruction of bones. This involves physically implanting devices into the body to stabilize and repair bone structures.
- No Mention of Biological Samples or Testing: The document does not mention any interaction with biological samples or any form of diagnostic testing performed outside of the body.
Therefore, the Flower Small and Medium Implants set is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
Product codes
HRS, HWC
Device Description
The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot
Indicated Patient Age Range
adults and for long bone in adolescents (12-21) in whom the growth plates have fused
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)
In support of this 510(k) Premarket Notification, Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Flower Small and Medium Implant Set (K123562), Synthes USA's 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807), Stryker's VariAx Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks (K112455), KLS-Martin Hand Plating System (K040598)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
5.510(K) SUMMARY
| Submitter's Name: | Flower Orthopedics Corporation |
|---|---|
| Submitter's Address: | 7715 Crittenden Street, #413 |
| Philadelphia, PA 19118 | |
| Submitter's Telephone: | 267-437-3063 |
| Submitter's Fax: | 267-437-3072 |
| Authorized Contact Name: | Janice M. Hogan |
| Contact's Telephone: | 267-675-4611 |
| Contact's Email: | janice.hogan@hoganlovells.com |
| Date Summary was | |
| Prepared: | July 26, 2013 |
| Trade or Proprietary Name: | Flower Small and Medium Implant Set |
| Common or Usual Name: | Bone plating system |
| Classification: | Class II per 21 CFR §888.3030 |
| Product Codes: | HRS, HWC |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Flower Small and Medium Implant Set (K123562) |
| Synthes USA's 3.5 mm and 4.5 mm Locking | |
| Compression Plate (LCP) System with | |
| Expanded Indications (K082807) | |
| Stryker's VariAx Distal Radius Locked Plating System | |
| Line Extension for Addition of Aiming Blocks | |
| (K112455) | |
| KLS-Martin Hand Plating System (K040598) |
CHANGE FROM PREDICATE:
The purpose of this submission is to make modifications (line extensions) to the components of the Flower Small and Medium Implant Set cleared in K123562. The standard construct is modified by adding sizes not included in the previous submission.
TECHNOLOGICAL CHARACTERISTICS:
The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments.
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INDICATIONS FOR USE
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
Performance Data
In support of this 510(k) Premarket Notification, Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use.
CONCLUSION
The Flower Small and Medium Implants system is very similar to previously cleared Flower Small and Medium Implant Set. The Flower Small and Medium Implants system has the same intended uses and similar indications, technological characteristics, and principles of operation as the previously cleared devices. The minor technological differences between the subject Flower Small and Medium Implants and its previously cleared devices raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that Flower Small and Medium Implant Set is substantially equivalent to the previously cleared devices.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Flower Orthopedics Corporation % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1835 Market Street. 29th Floor Philadelphia, Pennsylvania 19103
Re: K131657
Trade/Device Name: Flower Small and Medium Implant Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 26, 2013 Received: July 26, 2013
Dear Ms. Hogan:
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
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Page 2 - Ms. Janice M. Hogan
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.hun 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/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Device Name: Flower Small and Medium Implant Set
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices