(61 days)
Not Found
No
The summary describes a porous HDPE surgical implant, a material-based device, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as "Surgical Implants" intended for "augmentation or reconstruction of the craniomaxillofacial skeleton," which are therapeutic applications.
No
The device is described as an implant for augmentation or reconstruction, not for identifying the presence or absence of a disease or condition.
No
The device description explicitly states it is manufactured of porous high density polyethylene (HDPE), which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided information clearly states that this device is a "Porous HDPE Surgical Implant" intended for "augmentation or reconstruction of the craniomaxillofacial skeleton." This describes a device that is surgically implanted into the body.
The device's function is to physically replace or augment bone structure, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Product codes (comma separated list FDA assigned to the subject device)
77JOF, 84JBA, 79LZK, 86FWO, 77JAZ, 79ESR, 77JCS, 77LGK, 79FZE, 77ESY, KKY
Device Description
ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial skeleton
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.
0
510(k) SUMMARY
Porous HDPE Surgical Implants
KO22665_
OCT 0 9 2002
ePor, Inc. 731 1/2 N. LaBrea Avenue Los Angeles, CA 90038 Tel: (323) 549-3831, Fax: (323) 549-3834
CONTACT CONTACT CONTACT CONTACT
Eric V. Hohenstein Tel: (323) 549-3831 Fax: (323) 549-3834
NAME OF DEVICE________________________________________________________________________________________________________________________________________________________________
Trade Name: Porous HDPE Surgical Implants, to be distributed under various trademarks including ePor, Biopor, Minopor, and p-HDPE.
Common Name: Preshaped porous polyethylene implants suitable for implantation into cranial and facial areas.
DEVICE CLASSIFICATION ________________________________________________________________________________________________________________________________________________________
| NOMENCLATURE | CLASS NO. | CLASS | REG NO. |
|---|---|---|---|
| POLYMER ENT SYNTHETIC, POROUS POLYETHYLENE | 77JOF | II | 874.3620 |
| PROSTHESIS, CRANIOFACIIAL | 84JBA | II | 882.5330 |
| IMPLANT, MALAR | 79LZK | II | |
| PROSTHESIS, EYE, INTERNAL | 86FWO | II | 886.3200 |
| PROSTHESIS, FACIAL, MANDIBULAR IMPLANT | 77JAZ | II | 874.3695 |
| PROSTHESES/NASAL DORSAL IMPLANT | 79ESR | II | 878.3680 |
| PROSTHESIS, MAXILLA | 77JCS | II | |
| PROSTHESIS, MAXILLOFACIAL | 77LGK | ||
| PROSTHESIS, NOSE, NTERNAL | 79FZE | II | 878.3680 |
| PROSTHESIS, OTOPLASTY | 77ESY | II | 878.3590 |
1
K022665 page 2/2
STATEMENT OF SUBSTANTIAL EQUIVALENCE__________________________________________________________________________________________________________________________________________
ePor, Inc. Porous HDPE Surgical Implants are substantially equivalent to the Medpor® Surgical Implant Material; Preformed Cranial and Facial Implants K922489, based on the subject devices' similarity to the predicate devices in intended use, material, design, and surgical procedure.
INDICATIONS FOR USE
ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
DESCRIPTION __________________________________________________________________________________________________________________________________________________________________
ePor, Inc. Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are manufactured of porous high density polyethylene (HDPE), a material that has been used in craniofacial reconstruction for over 25 years.
Porous polyethylene is recognized as acceptable for implantation purposes through the folowing device classification per 21 Code of Federal Regulations.
| CLASS NO. | CLASS | REG NO. | |
|---|---|---|---|
| POLYMER ENT SYNTHETIC, POROUS POLYETHYLENE | 77JOF | II | 874.3620 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a wavy, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0 9 200
Mr. Eric Hohenstein ePor, Inc. 731 ½ N. LaBrea Avenue Los Angeles, California 90038
Re: K022665
Trade/Device Name: Porous HDPE Surgical Implants Regulatory Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with Carbon Fibers Composite Implant Material
Regulatory Class: II Product Code: KKY Dated: August 6, 2002 Received: August 9, 2002
Dear Mr. Hohenstein:
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 - Mr. Eric Hohenstein
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Styph Rhodes
M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
..
| APPLICANT: | ePor, Inc. |
|---|---|
| 510(k) NUMBER: (if known): | K022665 |
DEVICE NAME: Porous HDPE Surgical Implants
INDICATIONS FOR USE:
Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K022665 |
| OR Over-The-Counter Use | |
| Prescription Use | |
| (Per 21 CFR 801.109) | (Optional) |