(133 days)
Not Found
No
The submission describes a change only to the packaging of existing medical devices, specifically to create an inert environment using nitrogen flushing and vacuum sealing. There is no mention of any software, algorithms, or data processing that would involve AI or ML.
No
The document states that the devices are "Osteonics implants which contain UHMWPE as a bearing," implying they are components of implants, not therapeutic devices themselves. The submission primarily addresses changes to packaging methods to retard oxidation, not to the therapeutic function of the device.
No
The document describes a packaging change for Osteonics implants containing UHMWPE, which are hip and knee joint components. These are therapeutic/implantable devices, not devices used for diagnosis.
No
The 510(k) summary describes changes to the packaging of physical medical devices (UHMWPE implants) and does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic). Here's why:
- Intended Use/Indications for Use: The text explicitly states the packaging change does not affect the intended uses of the components, which are described as "Osteonics implants which contain UHMWPE as a bearing." These are clearly medical implants intended for use within the body, not for testing samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the implants (containing UHMWPE as a bearing) and the packaging method (double blister, nitrogen flush, vacuum seal). This aligns with the description of a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The submission is about a packaging change for existing medical implants, not a new diagnostic device.
N/A
Intended Use / Indications for Use
The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.
Product codes
Not Applicable
Device Description
The devices which are subject to the proposed packaging change are Osteonics implants which contain UHMWPE as a bearing. These devices all have their own, previously established 510(k) clearances. This 510(k) does not address any changes to any component or its device description; it addresses only a change to the way that the devices will be packaged.
As before, Osteonics' UHMWPE devices will continue to be packaged according to the previously featured "double blister" style method. However, in order to create an inert environment, the component packages will be flushed with Nitrogen and then vacuum sealed. This "N,/Vac" feature requires the following changes to the package itself:
- The current blister material is replaced with a less gas-permeable material.
- The current lid stock is replaced with a less gas-permeable lid stock.
- The inner/outer blister assembly will be placed within a pouch, adding another gas transmission barrier to the final package.
The proposed change in Osteonics' packaging does not affect the device sterility. The sealed inner and outer packaging blisters meet the same package and seal requirements as the traditional Osteonics' packaging. The radiation dose required for sterility is not affected by the new packaging materials, and the sterility assurance level (SAL) of 106 remains unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
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.
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
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
510(k) Premarket Notification Summary of Safety and Effectiveness for Change in Packaging for Osteonics' UHMWPE Components
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Terry Jarosz
Regulatory Affairs Specialist |
| Date of Summary Preparation: | February 26, 1996 |
| Device Identification | |
| Proprietary Name: | Osteonics® N2/Vac Packaging
Process |
| Common Name: | Nitrogen flush/vacuum sealing
packaging process |
| Classification Name and Reference: | Not Applicable |
Predicate Device Identification
Devices packaged under the Osteonics® N,/Vac Packaging Process are substantially equivalent to devices packaged under standard, room air conditions, as well as to devices packaged under the various, other packaging methods recently put forth by other orthopedic implant manufacturers. The following predicate 510(k)s are identified for comparison:
- K934060: Howmedica Acetabular Components Packaging and Manufacturing Methods ● Change
- K936292: Howmedica Knee Components Packaging and Manufacturing Methods Change
- K940743: DePuy Vacuum Nitrogen (N2) Flush - Barrier Packaging
1
Device Description
The devices which are subject to the proposed packaging change are Osteonics implants which contain UHMWPE as a bearing. These devices all have their own, previously established 510(k) clearances. This 510(k) does not address any changes to any component or its device description; it addresses only a change to the way that the devices will be packaged.
Intended Use:
The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.
The components which contain UHMWPE as a bearing will be packaged in an inert environment. The packaging method will reduce the oxygen content within the package, thereby retarding oxidation.
Statement of Technological Comparison:
As before, Osteonics' UHMWPE devices will continue to be packaged according to the previously featured "double blister" style method. However, in order to create an inert environment, the component packages will be flushed with Nitrogen and then vacuum sealed. This "N,/Vac" feature requires the following changes to the package itself:
Changes to Actual Package:
-
- The current blister material is replaced with a less gas-permeable material.
-
- The current lid stock is replaced with a less gas-permeable lid stock.
-
- The inner/outer blister assembly will be placed within a pouch, adding another gas transmission barrier to the final package.
The proposed change in Osteonics' packaging does not affect the device sterility. The sealed inner and outer packaging blisters meet the same package and seal requirements as the traditional Osteonics' packaging. The radiation dose required for sterility is not affected by the new packaging materials, and the sterility assurance level (SAL) of 106 remains unchanged.