(89 days)
Not Found
No
The summary describes a simple mechanical device made of titanium and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated to stop massive presacral hemorrhage during surgery, which is a therapeutic intervention.
No
The device is described as an implantable pin to stop hemorrhage during surgery, which is a treatment, not a diagnostic function.
No
The device description explicitly states it is a physical pin made of titanium, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "STOP MASSIVE PRESACRAL HEMORRHAGE DURING SURGERY". This describes a direct intervention on a patient's body to treat a condition.
- Device Description: The device is a physical pin made of titanium, designed for implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not involve the analysis of specimens.
Therefore, the Hemorrhage Occluder Pin is a surgical device intended for direct use on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"THE HEMORRHAGE OCCLUDER PIN IS INDICATED TO BE USED TO STOP MASSIVE PRESACRAL HEMORRHAGE DURING SURGERY"
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
"HEMORRHAGE OCCLUDER PIN (HOP) is of 7mm length and 8mm pinhead. It is made out of medical grade Titanium suitable for implantation."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
"presacral"
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"during surgery"
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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
FEB 0 3 2003
510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | Mansour Consulting LLC |
|---|---|
| 2-Address: | 1308 Morningside Park Dr |
| Alpharetta, GA 30022 USA | |
| 3-Phone: | (678) 908-8180 |
| 4-Fax: | (425) 795-9341 |
| 5-Contact Person: | Jay Mansour |
| 6-Date summary prepared: | November 1st, 2002 |
| 7-Device Trade or Proprietary Name: | HEMORRHAGE OCCLUDER PIN (HOP) |
| 8-Device Common or usual name: | Implantable Staple |
| 9-Device Classification Name: | Staple, Implantable |
| 10-Substantial Equivalency is claimed against the following device: | |
| • Hemorrhage Occludor from Surgeon Surgical Instrumentation, Inc. |
- 510k # K890447
11-Description of the Device:
HEMORRHAGE OCCLUDER PIN (HOP) is of 7mm length and 8mm pinhead. It is made out of medical grade Titanium suitable for implantation.
12-Intended use of the device:
This device is indicated to be used to stop massive presacral hemorrhage during surgery.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
5 of 6
1
Image /page/1/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized eagle with three wing segments, symbolizing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
Marina Medical Instruments, Inc. c/o Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K023725
Trade Name: Hemorrhage Occluder Pin (HOP) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: November 1, 2002 Received: November 6, 2002
Dear Mr. Mansour:
We have reviewed your Section 510(k) premarket 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) 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.
2
Page 2 - Mr. Jay Mansour
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Miriam C. Provost
to( Celia 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
3
Page 1 of
510(k) Number (if known): K023725
Device Name: HEMORRHAGE OCCLUDER PIN
Indications For Use:
THE HEMORRHAGE OCCLUDER PIN IS INDICATED
TO BE USED TO STOP MASSIVE PRESACRAL
HEMORRHAGE DURING SURGERY
(PLEASIE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P/ NEEDED)
ાર
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
vision of General, Restorative id Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Forma
(6) of (6)