(50 days)
Not Found
Not Found
No
The description focuses on hardware components and basic software for pressure measurement and display, with no mention of AI or ML terms or functionalities.
No
The device is intended for the measurement of intracompartmental pressures, which is a diagnostic function, not a therapeutic one. It provides information but does not treat or alleviate a medical condition.
Yes
The device is described as a "Compartmental Pressure Monitoring System" intended for "immediate or continuous measurement of intracompartmental pressures," which is a diagnostic function to assess a patient's condition.
No
The device description explicitly states it consists of a hand-held monitoring device, a pressure measurement probe, and an optional extension cable, all of which are hardware components. The software is housed within the hand-held device, but the system is not solely software.
Based on the provided information, the Synthes (USA) Compartmental Pressure Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Synthes system directly measures pressure within a compartment of the body (intracompartmental pressure). It does not analyze specimens outside the body.
- Intended Use: The intended use is the measurement of intracompartmental pressures, which is a direct physiological measurement, not an analysis of a bodily fluid or tissue sample.
Therefore, this device falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.
Product codes (comma separated list FDA assigned to the subject device)
LXC
Device Description
The Synthes (USA) Compartmental Pressure Monitoring System consists of a hand-held monitoring device, a re-sterilizable pressure measurement probe, and an optional extension cable. The hand-held monitoring device houses the operational software and the LCD display. The pressure measurement probe connects directly to the hand-held unit or can be attached using the optional extension cable. A 9-volt battery powers the monitor. The probe is inserted into the target compartment via a 14-gauge catheter supplied by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Not Found
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
N/A
0
3. Summary of Safety and Effectiveness Information [510(k) Summary]
:
:
·
| JUL 0 8 2003 | |
|---|---|
| Sponsor | Synthes (USA) |
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| Lisa M. Boyle | |
| (610) 647-9700 | |
| Name of the Device | Synthes (USA) Compartmental Pressure Monitoring System |
| Device Classification(s) | Class II - Monitor, Pressure, Intercompartmental |
| Device Description | The Synthes (USA) Compartmental Pressure Monitoring System |
| consists of a hand-held monitoring device, a re-sterilizable pressure | |
| measurement probe, and an optional extension cable. The hand-held | |
| monitoring device houses the operational software and the LCD | |
| display. The pressure measurement probe connects directly to the | |
| hand-held unit or can be attached using the optional extension cable. | |
| A 9-volt battery powers the monitor. The probe is inserted into the | |
| target compartment via a 14-gauge catheter supplied by the user. | |
| Indications | The Synthes (USA) Compartmental Pressure Monitoring System is |
| intended for the immediate or continuous measurement of | |
| intracompartmental pressures. | |
| Substantial Equivalence | Documentation is provided which demonstrates that the Synthes |
| (USA) Compartmental Pressure Monitor is substantially equivalent | |
| to other legally marketed devices. |
CONFIDENTIAL
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 8 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K031555
Trade/Device Name: Synthes (USA) Compartmental Pressure Monitoring System Regulatory Class: Unclassified Product Code: LXC Dated: May 15, 2003 Received: May 19, 2003
Dear Ms. Boyle:
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.
2
Page 2 - Ms. Lisa M. Boyle
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. 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) you may obtain. 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,
Miriam C. Provost
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
2. Indications for Use Statement
KOSISSS 510(k) Number (if known):
Device Name: Synthes (USA) Compartmental Pressure Monitoring System
Indications for Use: The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K031555 |
|---|---|
| --------------- | --------- |
Synthes(USA) Compartmental Pressure Monitoring System 510(k) CONFIDENTIAL