(242 days)
WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
The WELLGRAFT PE I Resorbable Bone Void Filler consists of high purity grade calcium sulfate hemihydrate powder and mixing solution. When mixed according to the directions, WELLGRAFT PE I Resorbable Bone Void Filler forms the biodegradable, biocompatible and rediopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE I Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 60~90 days and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.
This 510(k) summary describes a resorbable bone void filler and primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies with quantitative acceptance criteria. As such, several of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) are not present in the provided text.
Here is the information extracted and organized based on your request:
Acceptance Criteria and Device Performance
The provided document does not list specific quantitative acceptance criteria with corresponding device performance metrics in a tabular format. Instead, it states that the device "conforms to applicable standards."
| Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993 series for Biological evaluation of medical devices. | Device conforms to ISO 10993 series. |
| Material Purity: Conformance to ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. | Device conforms to ASTM F2224-03. |
| Sterilization: Conformance to ANSVAAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization. | Device conforms to ANSVAAMI/ISO 11137. |
| Resorption: Resorbs and is replaced with new bone during the healing process. | After implantation, it will be resorbed in approximately 60~90 days and be replaced by new bone during the healing process. |
| Osteoconductivity: Acts as a scaffold and facilitates new bone growth. | WELLGRAFT PE I Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. |
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The submission relies on "bench testing" and
- Data Provenance: Not specified, but the testing would have been conducted by the manufacturer (GWOWEI Technology CO., LTD., Taiwan) or a contracted lab. The document indicates a 510(k) submission from Taiwan.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device's evaluation primarily relies on material characteristic standards and substantial equivalence to a predicate, not diagnostic accuracy studies requiring expert-established ground truth.
-
Adjudication method for the test set:
- Not applicable. There is no mention of a diagnostic accuracy or clinical study requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The provided text does not describe an MRMC comparative effectiveness study. The evaluation focuses on material properties and substantial equivalence.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (bone void filler), not a software algorithm.
-
The type of ground truth used:
- The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, AAMI/ISO) for material properties, biocompatibility, and sterilization, along with comparison to the predicate device's established safety and effectiveness. The in-vivo performance claimed (resorption, osteoconductivity) is a characteristic of the material type, which is demonstrated to be similar to the predicate.
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
-
How the ground truth for the training set was established:
- Not applicable.
{0}------------------------------------------------
510(K) SUMMARY
APR - 4 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | GWOWEI Technology CO., LTD. |
|---|---|
| Address: | 5F, No. 99, Sec. 1, Jhongcheng Rd., Shilin District , Taipei City , |
| TAIWAN | |
| Phone: | +886-2-28380066 |
| Fax: | +886-2-28385255 |
| Contact: | Mr. Wilson Yeh / Manager |
| 2. Device Name : | |
| Trade Name: | WELLGRAFT PE I Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | WELLGRAFT PE I Resorbable Bone Void Filler have been |
| classified as | |
| Regulatory Class: II | |
| Product Code: MQV | |
| Panel : Orthopedic | |
| Regulation Number: 21CFR 888.3045 | |
| 4. Predicate Device: | The predicate device is the |
| • OSTEO-G BONE VOID FILLER SYSTEM (K031319) | |
| marketed by ASPINE USA, INC. | |
| 5. Device Description: | The WELLGRAFT PE I Resorbable Bone Void Fillerconsists of high purity grade calcium sulfate hemihydratepowder and mixing solution. When mixed according to thedirections, WELLGRAFT PE I Resorbable Bone Void Filler formsthe biodegradable, biocompatible and rediopaque paste orputty, and can then be digitally applied directly or by injectioninto the defect site. |
| WELLGRAFT PE I Resorbable Bone Void Filler isosteoconductive which acts as a scaffold and facilitate newbone growth. After implanted, it will be resorbed inapproximately 60~90 days and be replaced by new boneduring the healing process. This product is supplied sterilefor single patient use. | |
| Product:Page 1 of 2 | WELLGRAFT PE I Resorbable Bone Void FillerSection 4 - 510(k) SummaryREV. (C) |
.
{1}------------------------------------------------
Ko7a44y
- WELLGRAFT PE I Resorbable Bone Void Filler is indicated 6. Intended Use: to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. WELLGRAFT PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
- The device conforms to applicable standards includes ISO 7. Performance 10993 series : Biological evaluation of medical devices , ASTM Summary: F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization ----etc.
8. Conclusions:
The WELLGRAFT PE I Resorbable Bone Void Filler has the same intended use and similar technological characteristics as the OSTEO-G BONE VOID FILLER SYSTEM (K031319) marketed by ASPINE USA, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the WELLGRAFT PE I Resorbable Bone Void Filler is substantially equivalent to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GWOWEI Technology Co., Ltd. % Harvest Consulting Corporation Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, AZ 86001
APR - 4 2008
Re: K072444
Trade/Device Name: Wellgraft PE I Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 2, 2008 Received: April 3, 2008
Dear Ms. Reich:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.
{3}------------------------------------------------
Page 2 - Ms. Jennifer Reich
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K#072444
Device Name: WELLGRAFT PE I Resorbable Bone Void Filler GWOWEI Technology CO., LTD.
Indications for Use:
WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neith R.P. Gohm for mx
Division S Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K072444
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.