(70 days)
No
The summary describes a physical implant material and its intended use in surgery. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
Explanation: HAPSET is intended for use in facial reconstructive surgery to correct contour defects, functioning as an implant to restore or improve the structure and function of facial tissues, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a paste implant used in facial reconstructive surgery to correct contour defects, not to diagnose medical conditions.
No
The device description clearly outlines a physical implant material (hydroxylapatite and calcium sulfate) and associated hardware (mixing cup, syringe, instruments) for surgical delivery. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that HAPSET is for use in "facial reconstructive surgery as a paste implant that will set up into a solid block implant". This describes a device that is implanted directly into the body to correct physical defects.
- Device Description: The description details the components (hydroxylapatite, calcium sulfate, diluent) and how they are mixed and delivered for implantation. This aligns with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific analytes, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. HAPSET's function is to physically augment and correct structural defects, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
HAPSET is intended for use in facial reconstructive surgery as a paste implant that will set up into a solid block implant of hydroxylapatite and medical grade calcium sulfate. This hydroxylapatite block serves to correct contour defects of facial structures such as chin, mandible, malar region, and maxilla.
HAPSET use is being expanded for indications that include augmentation of the chin or cheek defects such as those created during autogenous bone grafting, and fracture reduction.
Product codes
Not Found
Device Description
HAPSET consists of hydroxylapatite particulate which 15 supplied dry, in a mixing cup with medical grade calcium sulfate. The dry material is packaged with a diluent in a syringe that -İs used to mix with the separate hydroxylapatite/calcium sulfate. The resulting product is a paste-like plaster that is delivered with the appropriate instruments to the prepared surgical site and molded to the desired contours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chin, mandible, malar region, and maxilla
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)
Nonclinical Test:
HAPSET has been found to be non-toxic, non-irritating, and non-hemolytic.
Clinical Test:
Reports in the literature indicate that the use of hydroxylapatite particles for aesthetic and medical augmentation have been successful since at least 1985. Clinicians are reporting that the implanted hydroxylapatite is biocompatible, stable and provides successful augmentation. The only reported drawback of the hydroxylapatite particles has been migration of the particles. HAPSET, in its plaster form, stabilize the particles and lessen the opportunity for particle migration by the setting of the implant into a solid block implant.
Further, HAPSET has been commercially distributed by Lifecore since 1991, cleared for marketing by 510(k) K910432. No side effects, adverse events or toxic symptoms have been reported to date according to Lifecore and MDR databases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K910432, K842163, K852766, K943186, K955096
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.
0
B
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510 (k) SUMMARY
D
ME
JUN 2 8 1996
1.1 Manufacturer's Name:
Lifecore Biomedical Inc. 3515 Lyman Blvd. Chaska, MN 55318
I C A L
(612) 368-4300 (612)368-3411 - FAX Contact Person: Lynn Cuperus
Date Prepared: April 8, 1996 1.2
1-3 Device Name: HAPSET hydroxylapatite/calcium sulfate plaster
1.4 Common Name: Prosthesis, Pacial augmentation implant
1.5 Classification:
Implant for cheek and chin, facial/cranial contour filling and bone augmentation for use with oralmaxillofacial fracture reduction procedures.
1.6 Substantially Equivalent Devices:
Prosthesis, Chin, Internal Implantech Interpore Vitek
Mesh, Surgical, Polymeric Davol Ethicon Gambro W.L. Gore and Associates Prosthesis, PTFE/Carbon Fiber vitek Polytetrafluoroethylene Vitreous Carbon Materials for Maxillofacial Reconstruction Biomet Kimberly-Clark Deminieralized Bone Graft products Grafton Tissue Bank sources
3 5 1 5 - 5 6 1 2 - 3 6 - 6 1 2 - 3 6 - 6 1 2 - 3 6 - 3 0 5 1 - U S A 612 - 3 6 8 - 4 3 0 0 F A X : 6 1 2 - 3 6 8 - 3 4 1 1
1
Kabisii 2.43
1.7 Device Description
HAPSET consists of hydroxylapatite particulate which 15 supplied dry, in a mixing cup with medical grade calcium The dry material is packaged with a diluent in a sulfate. syringe that -İs used to mix with the separate hydroxylapatite/calcium sulfate. The resulting product is a paste-like plaster that is delivered with the appropriate instruments to the prepared surgical site and molded to the desired contours.
1.8 Intonded Use:
HAPSET is intended for use in facial reconstructive surgery as a paste implant that will set up into a solid block implant of hydroxylapatite and medical grade calcium sulfate. This hydroxylapatite block serves to correct contour defects of facial structures such as chin, mandible, malar region, and maxilla.
-
1.9 Technological Characteristics:
HAPSET is manufactured, from hydroxylapatite particles and medical grade calcium sulfate. The hydroxylapatite particles chemically equivalent to the hydroxylapatite blocks are commercially distributed for the same intended use. other substantially equivalent devices with the same intended use are manufactured from materials such as silicone, PTFE, PTFE with carbon fibers, and vitreous carbon. Hydroxylapatite and medical grade calcium sulfate are known to be biocompatible and non-toxic which is an advantage over some of the other materials currently available. -
1.10 Nonclinical Test:
HAPSET has been found to be non-toxic, non-irritating, and This is the same or an improvement over the non-hemolytic. toxicological profiles of the other material available for this intended use.
1.11 Clinical Test:
Reports ជួ the literature indicate that the use or hydroxylapatite particles for aesthetic and medical augmentation have been successful since at least 1985. Clinicians are reporting that the implanted hydroxylapatite is biocompatible, stable and provides successful augmentation. The only reported drawback of the hydroxylapatite particles has been migration of the particles. HAPSET, in its plaster form, stabilize the particles and lessen the opportunity for particle migration by the setting of the implant into a solid block implant.
2
K961511 3 of3
Further, HAPSET has been commercially distributed by Lifecore since 1991, cleared for marketing by 510(k) K910432. No side effects, adverse events or toxic symptoms have been reported to date according to Lifecore and MDR databases. The HA-500 portion of HA is commercially marketed under 510(k) K842163 and K852766. Calcium Sulfate is marketed under the trade name CAPSET and was cleared to market via K943186 and K955096. All of these related devices have been shown in the medical industry to be non-toxic, safe and effective for the intended use on the product labeling.
- 1.12 Conclusions:
HAPSET, when used according to labeled directions, provides an implant that is substantially equivalent to hydroxylapatite blocks and other facial implants as noted. It İs biocompatible and has demonstrated clinical safety and effectiveness for the same intended use as the gurrent labeling applications listed. HAPSET use is being expanded for indications that include augmentation of the '
chin or cheek defects such as those created during autogenous bone grafting, and fracture reduction.
095