(332 days)
No
The description focuses on the mechanical components and surgical procedure, with no mention of AI or ML. Performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is intended to repair Pectus Excavatum and other anterior chest wall deformities by physically lifting the sternum, directly treating a medical condition.
No
The device is described as a surgical instrument used to surgically repair pectus excavatum by lifting the sternum, not to diagnose a condition.
No
The device description explicitly states it consists of a "pectus bar and stabilizer" and "appliance accessories" used in a surgical procedure, indicating it is a physical medical device, not software only.
Based on the provided information, the Park's Pectus System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical procedures to repair physical deformities of the chest wall. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (pectus bar and stabilizer) and surgical instruments used to correct a structural issue. It does not analyze biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
The Park's Pectus System is a surgical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
Park’s Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.
Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sternum and anterior chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use only by professional orthopedists
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)
Non-clinical performance tests, including 4-point bending test, 4-point bending fatigue test, vertical tensile test, were performed by comparing Park's pectus system with Lorenz pectus support bar system (K061384). The selection rationale of the test sample was based on the worst case scenario, a pectus bar with the longest and thinnest in size. All Park's pectus bar has the same width. The size of Park's pectus bars tested are 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. For material, both stainless and titanium pectus bars were tested. Pectus bars with both rounded end and serrated end were also tested. Other accessories (fixator driver, applier, bar removal bender, clamp, flipper, table top bender, easy crane system, flare compressor, and fixator container) were not considered in this test since there have been well established safety and effectiveness history for class I stainless and titanium surgical instruments.
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.
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
§ 888.3030 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
March 19, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.
TDM Co. Ltd. % Dave Kim Medical Device Regulatory Affairs Dave Kim 1830 Buffalo Speedway Houston, Texas 77025
Re: K191057
Trade/Device Name: Park's Pectus System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: April 10, 2019 Received: April 22, 2019
Dear Dave Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191057
Device Name Park's Pectus System
Indications for Use (Describe)
Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K191057
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: 2/17/2020
1. 510K Applicant / Submitter:
TDM CO., LTD. 69, Cheomdan venture so-ro 37beon-gil, Buk-gu, Gwangju, 61003, REPUBLIC OF KOREA Tel: +82-62-971-7460 Fax: +82-62-971-7461 Establishment registration number: 3014257776
2. Submission Contact Person
Dave Kim, MBA Mtech Group 7707 Fannin St. Ste 200. V111 Houston, TX 77054 Phone: 713-467-2607 Email: davekim@mtech-inc.net
3. Device
| - Trade / Device Name : | Park's Pectus System |
|---|---|
| ------------------------- | ---------------------- |
- -. Common Name : Pectus Excavatum System
- -. Classification Name : Plate, Fixation, Bone
- -. Regulation Number : 21 CFR 888.3030
- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class : II
- -. Product Code : HRS
4. Primary predicate Device
-
-. Trade / Device Name : Lorenz Pectus Support Bar System
II -
-. 510(k) Number : K061384
-
-. Regulation Number : 21 CFR 888.3030
-
-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-
-. Regulatory Class :
-
-. Product Code : HRS
5. Reference Device
5.1 Reference Device #01
| -. Trade / Device Name : | TDM Plate and Screw System |
|---|---|
| -. 510(k) Number : | K171808 |
| -. Regulation Number : | 21 CFR 888.3030 |
4
- -. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
- -. Regulatory Class :
- -. Product Code : HRS. HWC
5.2 Reference Device #02
-
-. Trade / Device Name : TDM Plate and Screw System
II -
-. 510(k) Number : K190391
-
-. Regulation Number : 21 CFR 888.3030
-
-. Regulation Name : Single/multiple component metallic bone fixation appliances and accessories
-
-. Regulatory Class : II
-
-. Product Code : HRS. HWC
6. Description:
Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.
Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.
7. Indications for Use
Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.
8. Substantial Equivalence Discussion:
The Park's Pectus System is substantially equivalent to Lorenz Pectus Support Bar System (K061384). The following comparison table is presented to demonstrate substantial equivalence.
| | Candidate Device | Primary predicate | Substantial
Equivalence
Analysis |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | K191057 | K061384 | - |
| Device Name | Park's Pectus System | Lorenz Pectus Support Bar System | - |
| Common Name | Single/multiple component
metallic bone fixation appliances
and accessories | Single/multiple component
metallic bone fixation appliances
and accessories | - |
| Manufacturer | TDM CO., LTD. (Korea) | Biomet Microfixation Inc. (USA) | - |
| Indication for
Use | Park's Pectus System is intended
for use in surgical procedures to
repair Pectus Excavatum and other
anterior chest wall deformities. | This device is intended for use in
surgical procedures to repair
Pectus Excavatum and other chest
wall deformities. | Substantial
Equivalence |
| Indication | Congenital deformity of the
sternum and anterior chest wall | Congenital deformity of the
sternum and anterior chest wall | Substantial
Equivalence |
| Contraindicatio
n | - Patients with mental or
neurological conditions who are
unwilling or incapable of following
instructions.
- Patients presenting metal
sensitivity reactions. | - Patients with mental or
neurological conditions who are
unwilling or incapable of following
instructions. - Patients presenting metal
sensitivity reactions. | Substantial
Equivalence |
| | | | |
| | - Patients with insufficient quantity
or quality of bone or fibrous tissue
to allow remodeling. - Infection | - Patients with insufficient quantity
or quality of bone or fibrous tissue
to allow remodeling. - Infection | |
| Raw Material | Titanium Alloy (ASTM F136)
Stainless Steel (ASTM F138 &
ASTM F139) | Titanium Alloy (ASTM F136)
Stainless Steel (ASTM F138) | Substantial
Equivalence |
| Feature | - The Pectus Bar's rounded ends
and blunt edges help minimize
tissue destruction during implant
insertion. - The Pectus Bar comes in a variety
of lengths ranging from 6 inches to
17 inches to accommodate most
Pectus Excavatum correction
procedures - All instruments in the Pectus
System are designed to increase
simplicity during the Nuss
Procedure. - The Pectus System Container
comes in two sizes and
conveniently houses the entire
range of Pectus implants and
instruments - Specialized titanium bars and
stabilizers available for patients
with nickel allergies - Pectus-size bars available for the
following:
① Special sized bars
② Pre-bent bars developed in
accordance with patients' CT scans | - The Pectus Bar's rounded ends
and blunt edges help minimize
tissue destruction during implant
insertion. - The Pectus Bar comes in a variety
of lengths ranging from 7 inches to
17 inches to accommodate most
Pectus Excavatum correction
procedures. - All instruments in the Pectus
System are designed to increase
simplicity during the Nuss
Procedure. - The Pectus System Container
comes in two sizes and
conveniently houses the entire
range of Pectus implants and
instruments - Specialized titanium bars and
stabilizers available for patients
with nickel allergies - Pectus-size bars available for the
following:
① Special sized bars
② Pre-bent bars developed in
accordance with patients' CT scans | Substantial
Equivalence |
| Surgical
Procedure | MIRPE
(Minimally Invasive Repair of
Pectus Excavatum) | MIRPE
(Minimally Invasive Repair of
Pectus Excavatum) | Substantial
Equivalence |
| Pectus Bar
Length | 6 inch ~ 17 inch | 7 inch ~ 17 inch | Substantial
Equivalence |
| Single use | Yes | Yes | Substantial
Equivalence |
| Non-Sterile
Packaging | Yes | Yes | Substantial
Equivalence |
| Target
Population | Patients with congenital deformity
of the sternum and anterior chest
wall | Patients with congenital deformity
of the sternum and anterior chest
wall | Substantial
Equivalence |
| Anatomical Site | Sternum and anterior chest wall | Sternum and anterior chest wall | Substantial
Equivalence |
| Location of Use | Use only by professional
orthopedists | Use only by professional
orthopedists | Substantial
Equivalence |
| Bio-
compatibility | All user directly contacting
materials are compliance with
ISO10993 requirements. | All user directly contacting
materials are compliance with
ISO10993 requirements. | Substantial
Equivalence |
5
6
Park's Pectus System and the primary predicate device[Lorenz Pectus Support Bar System (K061384)] have identical indication for use statements and the same intended use.
The device specifications and materials are equal to the primary predicate device/Lorenz Pectus Support Bar System (K061384)] in all parameters.
The materials and sterilization method for Parks Pectus System including class I and class II accessories are identical to TDM plate and screw systems cleared by FDA (K190391)
Therefore, the Park's Pectus System is substantially equivalent to the primary predicate device[Lorenz Pectus Support Bar System (K061384)].
9. Performance Tests (Non-clinical)
Non-clinical performance tests, including 4-point bending test, 4-point bending fatigue test, vertical tensile test, were performed by comparing Park's pectus system with Lorenz pectus support bar system (K061384). The selection rationale of the test sample was based on the worst case scenario, a pectus bar with the longest and thinnest in size. All Park's pectus bar has the same width. The size of Park's pectus bars tested are 431.8 mm (17 inch) long x 12.7mm width x 2.8 mm thick. For material, both stainless and titanium pectus bars were tested. Pectus bars with both rounded end and serrated end were also tested. Other accessories (fixator driver, applier, bar removal bender, clamp, flipper, table top bender, easy crane system, flare compressor, and fixator container) were not considered in this test since there have been well established safety and effectiveness history for class I stainless and titanium surgical instruments.
-. ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates
10. Biocompatibility Tests
The materials for Parks Pectus System including class I accessories are identical to TDM plate and screw systems (K171808/K190391) cleared by FDA.
ASTM F138 & ASTM F139 stainless steel, the same materials used for Park's Pectus Bar System. have been raised in literature; no studies have conclusive evidence that metal wear debris or metal ions are carcinogenic.
"The [Titanium Alloy(ASTM F136)] of Park's Pectus Bar in its final finished form is identical to the [Titanium Alloy(ASTM F136)] of the [TDM Plate And Screw System (K171808/ K190391) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents)."
" Park's Pectus Bar in its final finished form is identical to [TDM Plate And Screw System (K171808/K190391) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, cleaning agents, mold release agents)."
7
11. Summary of Clinical Tests
Clinical testing was not required to demonstrate the substantial equivalence of the Park's Pectus System to its primary predicate device.
12. Conclusions:
Based on the information provided in this premarket notification, TDM CO., LTD. concludes that the Park's Pectus System is substantially equivalent to the primary predicate as described herein.