(75 days)
No
The description focuses on mechanical suction and filtration for bone collection, with no mention of AI/ML terms or functionalities.
No
The device is described as an aspirator for the removal and collection of biological materials, not for treating a disease or condition. Its function is to collect bone for autogenous grafting, which is a material collection process, not a therapeutic intervention by the device itself.
No
Explanation: The device is described as an aspirator for the removal and collection of fluids and bone chips during surgery, primarily for autogenous bone grafting. Its function is to collect materials, not to analyze, diagnose, or provide information about a medical condition.
No
The device description explicitly lists physical components such as a Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing, and a Plunger, indicating it is a hardware device.
Based on the provided information, the Odontit Autogenous Bone Collection Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Odontit Device Function: The Odontit device is used during surgery to collect bone chips and fluids directly from the surgical site. It is a surgical aspirator and bone collection tool.
- No Analysis of Samples: The device collects material, but it does not perform any diagnostic analysis or testing on the collected samples to provide information about a patient's health status. The collected bone is intended for use as an autogenous graft, not for diagnostic purposes.
Therefore, the Odontit Autogenous Bone Collection Device falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
Product codes
GCY
Device Description
The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
510(k) Premarket Notification Odontit Autogenous Bone Collection Device
ODONTIT S.A. Confidential -
510(k) SUMMARY
SUBMITTED BY
国家 | | |
Mario Gerzberg President ODONTIT S.A. Av. Rivadavia 5032 1*7 1424 Buenos Aires ARGENTINA Telephone: 011-541-902-9500 Facsimile: 011-541-903-9330
JUN - 3 1997
March 20, 1997 Date Submitted:
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name:
Common/Usual Name: Proprietary Name:
Non-powered. Single Patitent, Portable Suction Apparatus Disposable Aspirator Odontit Autogenous Bone Collection Device
PREDICATE DEVICE
KAM Super Sucker™ [reference 510(k) K822065 cleared 8/16/82]
DEVICE DESCRIPTION
The Odontit Autogenous Bone Collection Device is a portable suction device intended for use as an aspirator for the removal and collection of blood, autogenous bone, or other extraneous fluids from a surgical site. The device consists of the following components: Body Assembly, Aspirator Tip, Screen Filter, Flex tubing, Rigid tubing and a Plunger.
PRODUCT USE
- The package is opened and the contents removed. 1.
- The rigid tubing connector is attached to a vacuum source. 2.
- The aspirator tip is attached to the flexible tubing. 3.
- The Autogenous Bone Collection Device is used in accordance with বা standard surgical procedures and as required to remove blood, autogenous bone chips or other extraneous fluids from the surgical site.
-
- The lower body of the device is then aseptically separated from the upper body by twisting and carefully separating the two components.
- The Screen Filter assembly is then carefully removed using aseptic 6. technique.
- Wash or rinse the collected bone chips per standard procedure if 7. deemed necessary.
1
510(k) Premarket Notification Odontit Autogenous Bone Collection Device
ODONTIT S.A. - Confidential -
- Use the plunger to compact the bone chips as required. 8.
- Remove the Filter Standoff to harvest the bone chips for delivery to the ். surgical site.
INDICATIONS FOR USE:
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or Using a vacuum source, the other extraneous fluids from a surgical site. Odontititit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the "option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
WARNINGS AND PRECAUTIONS
Aseptic Technique Required
Warning: For one time use only - Do not resterilize.
Caution: Federal (USA) law restricts the use of this device to sale by or on the order of a licensed physician.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The product design, material of construction, and function as an aspirator is substantially equivalent to the FDA cleared predicate device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. Mario Gersberg President . . . . ... .. Interpore International 181 Technology Drive Irvine, California 92618
Re: K971036
Trade Name: Odontit Autogenous Bone Collection Device Regulatory Class: I Product Code: GCY Dated: March 20, 1997 Received: March 20, 1997
Dear Mr. Gersberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug, Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Mario Gersberg
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ODONTIT S.A. Confidential -
Page 1 of 1
大971036 510(k) Number (if known): Not Known
Device Name: Odontit Autogenous Bone Collection Device
Indications for Use:
:
The Odontit Autogenous Bone Collection Device is indicated for use as an aspirator for the removal and collection of blood, autogenous bone chips, or other extraneous fluids from a surgical site. Using a vacuum source, the Odontit aspirator will remove materials (including blood, bone chips and other fluids) from the surgical site and pass them through a stainless steel screen which is designed to capture and collect autogenous bone. At the option of the surgeon, this bone may be removed from the aspirator, washed and cleansed as necessary, and returned to the same patient as an autogenous bone graft.
The capacity for bone collection in the screen is approximately 16 cc.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971036 |
| Prescription Use
(PER 21 CFR 801.109) ✓ | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------------------- | ---- | -------------------------------------------------- |
|---|
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