(242 days)
WELLGRAFT PE II 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 II Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
The WELLGRAFT PE II Resorbable Bone Void Filler consists of high purity mixed grade calcium sulfate hemihydrate powder with different size calcium sulfate granules, and mixing solution. When mixed according to the directions, WELLGRAFT PE II Resorbable Bone Void Filler forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE II is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
The provided text is a 510(k) summary for the WELLGRAFT PE II Resorbable Bone Void Filler. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Based on the provided document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics for the WELLGRAFT PE II Resorbable Bone Void Filler. Instead, it states that the device "conforms to applicable standards."
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable acceptance criteria in the document. The document refers to conformance with general standards. | "Conforms to applicable standards includes ISO 10993 series : Biological evaluation of medical devices , ASTM 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." |
| Resorption time | "resorbed in approximately 90 days and replaced by new bone during the healing process." |
The study that proves the device meets the acceptance criteria is implicitly the set of "bench testing contained in this submission." The conclusion states that this bench testing demonstrates "any differences in their technological characteristics do not raise any new questions of safety or effectiveness" when compared to the predicate device. However, specific details of this bench testing and the direct link to performance against acceptance criteria are not elaborated.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" in the context of clinical or performance data. The evaluation appears to be based on "bench testing," which typically refers to laboratory experiments on the device itself, not human or animal subjects that would constitute a "test set" in the conventional sense for medical device performance.
- Sample size for test set: Not specified.
- Data provenance: The "bench testing" is referenced as being "contained in this submission," implying it was conducted by the submitter (GWOWEI Technology CO., LTD.). The document does not provide details on the location or nature (e.g., retrospective or prospective) of this testing beyond it being laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The evaluation relies on "bench testing" against standards, not on expert-established ground truth from clinical cases. There is no mention of experts being used to establish ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There is no mention of an adjudication method as no expert review of a test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a bone void filler, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical implant (bone void filler), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth," in this context, is conformance to established industry standards and regulatory requirements. This is verified through "bench testing" designed to assess material properties, biocompatibility, and other performance characteristics against the specified standards (e.g., ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as it's a 510(k) for a physical implant relying on substantial equivalence and bench testing.
8. The sample size for the training set
This information is not applicable. The device is a bone void filler, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
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510(K) SUMMARY
Ko72170
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| APR - 4 2008 | |
|---|---|
| 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 II Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | WELLGRAFT PE II Resorbable Bone Void Filler have beenclassified 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 II Resorbable Bone Void Fillerconsists of high purity mixed grade calcium sulfatehemihydrate powder with different size calcium sulfategranules, and mixing solution.When mixed according to the directions, WELLGRAFT PE IIResorbable Bone Void Filler forms the biodegradable,biocompatible and radiopaque paste or putty, and can then bedigitally applied directly or by injection into the defect site.WELLGRAFT PE II is osteoconductive which acts as a scaffoldand facilitate new bone growth. After implanted, it will be |
| Product:Page 1 of 2 | WELLGRAFT PE II Resorbable Bone Void FillerSection 4 - 510(k) SummaryREV. [C] |
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resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
-
- Intended Use: WELLGRAFT PE II 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 II Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
-
- Performance The device conforms to applicable standards includes ISO 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 II 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 II Resorbable Bone Void Filler is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" written around it. Inside the circle is an abstract image of an eagle with its wings spread.
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: K072170
Trade/Device Name: Wellgraft PE II Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV 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.
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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 cquivalence 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 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 N. Mulkern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K#072170
Device Name: WELLGRAFT PE II Resorbable Bone Void Filler GWOWEI Technology CO., LTD.
Indications For Use:
WELLGRAFT PE II 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 II Resorbable Bone Void Filler 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)
Neil R.E. Oglan for mxn
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K012170
Page 1 of 1
§ 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.