(167 days)
Not Found
No
The summary describes a mechanical surgical instrument and does not mention any AI or ML capabilities.
No
The device is a surgical clamp used for occluding vessels, which is an instrument, not a therapeutic device designed to cure or prevent a disease.
No
Explanation: The device is a surgical clamp, used for occluding vessels during surgery. Its function is to facilitate surgical procedures, not to diagnose medical conditions by providing information about the patient's health status.
No
The device is described as reusable, ring-handled stainless steel clamps and inserts, which are physical hardware components. The summary does not mention any software component.
Based on the provided information, the Koala Vascular Clamps and Inserts are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description clearly states that these clamps are used during surgery to clamp vessels within the body.
- The intended use is for surgical procedures on living patients. IVD devices are used to diagnose conditions by analyzing samples outside the body.
- The device description focuses on surgical instruments. The description details the physical characteristics and function of surgical clamps.
The information provided aligns with a surgical instrument used for direct intervention on a patient, not for analyzing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
vessels, pulmonary, gastrointestinal, peripheral, thoracic, aorta, vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and operating room (OR)
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for BOSS INSTRUMENTS LTD. The word "BOSS" is in large, bold letters, with a medical symbol inside the "O". Below the word "BOSS" is the phrase "INSTRUMENTS LTD." in smaller, block letters.
1 8 1898
For the Art of Surgery
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3
December 29, 1997
Boss Instruments. Ltd. 1310 Central Ct. Hermitage, TN 37076
Tel - (615) 885-2231 Fax - (615) 885-2992
| Official Contact: | Burns Phillips. President |
|---|---|
| Proprietary or Trade Name: | Koala Vascular Clamps and Inserts |
| Common/Usual Name: | Vascular Clamps and Accessories |
| Classification Name: | Vascular clamps |
| Device: | Koala Vascular Clamps and Inserts |
| Predicate Devices: | Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - |
| K951413 |
Device Description:
The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.
Indicated Use --
The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque. visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.
Environment of Use --
Hospital and operating room (OR)
Page 3 of 70
P.O. BOX 293180 NASHVILLE, TN 37229-3180 U.S.A.
TELEPHONE 615-885-2231 FAX 615-885-2992
1
Non-Confidential Summary of Safety and Effectiveness
page 2 of ?
December 29, 1997
Comparison to Predicate Devices:
| Attribute | Koala Clamps
and Inserts | Baxter -V. Mueller
Fogarty K951413 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------|
| Use | | |
| Indicated for clamping vessels
and total occlusion | Yes | Yes |
| Used in pulmonary, gastrointestinal,
peripheral clamping, thoracic
procedures - occlusion of aorta,
vena cava, cross clamping of aorta
and aortic aneurysms, etc. | Yes | Yes |
| Intended to be reused | Yes | Yes |
| Design | | |
| Instruments manufactured by the
same company | Yes | Yes |
| Various sizes and configurations
offered | Yes | Yes |
| Incorporate inserts to reduce trauma
available in 33, 61 and 86 mm sizes | Yes | Yes |
| Packaging | | |
| Inserts provided sterile in
Tyvek pouches | Yes | Yes |
| Clamps provided clean,
non-sterile | Yes | Yes |
| Materials | | |
| Clamps - Stainless Steel | Yes | Yes |
| Comparison to Predicate Devices: | | |
| Attribute | Koala Clamps
and Inserts | Baxter -V. Mueller
Fogarty K951413 |
| Materials | | |
| Inserts - polyurethane | Yes | Yes |
| Performance Standards / Specifications | | |
| Required under Section 514 | None | None |
| Biocompatability tests for Class VI
for the insert material | Yes | Yes |
.
2
Non-Confidential Summary of Safety and Effectiveness
page 3 of 3
December 29. 1997
Differences between Other Legally Marketed Predicate Devices
The clamps are manufactured and supplied by the same manufacturer. The inserts are manufactured by different companies, but the base material is exactly the same. Therefore there are no significant differences between the intended device and the predicate - Baxter - V. Mueller - Fogarty -Hydragrip Vascular Clamps and inserts approved under K951413.
page 5 of 70
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The caduceus is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text is in all caps.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 1998
Mr. Burns Phillips President Boss Instruments, Ltd. 1310 Central Ct. Hermitage, TN 37076
Re: K980002 Koala Vascular Clamps and Inserts Trade Name: Regulatory Class: II Product Code: DXC Dated: April 17, 1998 Received: April 21, 1998
Dear Mr. Phillips:
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 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). 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
4
Page 2 - Mr. Burns Phillips
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.
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) 594-4618. 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 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDIGATIONS FOREUSE
Page 1 of 1
K 980002 (To be assigned)
510(k) Number:
Device Name:
Koala Vascular Clamps and Inserts
The Koala Vascular Clamps and Inserts are reusable, ring-handled Intended Use : I ne Roule Vassena vassens for clamping delicate vessels during surgery. Statiness 1000 comments wisualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, purinemaly, grocedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Tia H
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices x990002 510(k) Number_
Prescription Use
(Per CFR 801.109) ✓
Over-the-counter use
Page 9 of 70