(136 days)
No
The document describes a mechanical implant for hip replacement and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is indicated for use in total hip arthroplasty to reduce or relieve pain and improve hip function, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This directly relates to the treatment and improvement of a patient's health condition, which defines a therapeutic device.
No
Explanation: The Delta Acetabular System is an implant used in total hip arthroplasty to treat conditions like degenerative joint disease and fractures, not to diagnose them.
No
The device description clearly outlines physical components made of titanium alloy, UHMWPE, ceramic, and Cobalt Chrome Molybdenum alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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 description clearly states that the Delta Acetabular System is a total hip arthroplasty system. It is a physical implant used to replace a damaged hip joint. Its intended use is to reduce pain and improve hip function in patients with various hip conditions.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens. It is surgically implanted into the body.
Therefore, based on the provided information, the Delta Acetabular System is a surgical implant/prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- Rheumatoid arthritis;
- Post-traumatic arthritis,
- Correction of functional deformity;
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- Revisions in cases of good remaining bone stock;
- Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
Product codes
LPH, MBL
Device Description
The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.
The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.
The design of shell is similar to the Delta TT Pro Acetabular System (K182099) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature patients
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
Mechanical testing had demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Push-out, lever-out and torque-out test according to ASTM F1820-13
- Stiffness test according to ISO 7206-12:2016
- Unsupported anatomical fatigue deformation
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
November 1, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting, LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K191622
Trade/Device Name: Delta Multihole TT Pro Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL Dated: October 9, 2019 Received: October 11, 2019
Dear Stephen Peoples:
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 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
1
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,
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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) K191622
Device Name
Delta Multihole TT Pro Acetabular System
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis,
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- · Revisions in cases of good remaining bone stock;
- · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
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
Summarv of Safety and Effectiveness
Date: September 12, 2019
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 Email: SPeoplesVMD@gmail.com
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| Delta Multihole TT Pro | ||
| Pro Acetabular System | LPH, MBL | Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis per 21 | ||
| CFR 888.3358 |
Common name:
Acetabular Cup System
Description:
The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.
The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.
The design of shell is similar to the Delta TT Pro Acetabular System (K182099) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.
Intended Use/Indications:
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular ● necrosis and hip dysplasia;
- Rheumatoid arthritis;
- Post-traumatic arthritis, ●
- Correction of functional deformity; ●
Traditional 510(k) – Delta Multihole TT Pro Acetabular System
4
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- Revisions in cases of good remaining bone stock;
- Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only). ●
The Delta Acetabular System is intended for cementless use.
Predicate Devices:
The LimaCorporate Delta Multihole TT Pro Acetabular System is similar to the following cleared devices in regards to design features, indications, and materials:
- -Delta TT Pro Acetabular System (LimaCorporate, K182099), primary predicate
- -G7 Acetabular System (Biomet, Inc., K140669)
Summarv of technology comparison:
The intended use, design, and materials of the Delta Multihole TT Pro Acetabular System are substantially equivalent to the intended use, design, and materials of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Non-clinical testing
Mechanical testing had demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Push-out, lever-out and torque-out test according to ASTM F1820-13 ●
- Stiffness test according to ISO 7206-12:2016 ●
- Unsupported anatomical fatigue deformation ●
Clinical testing
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices.