(167 days)
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.
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.
The provided text describes a 510(k) submission for the "Koala Vascular Clamps and Inserts," demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation of the device itself.
Therefore, many of the requested details, such as specific acceptance criteria and a study proving those criteria were met, are not available in the provided document. The document focuses on comparing the new device to an existing predicate device to establish substantial equivalence for regulatory approval.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document asserts substantial equivalence to a predicate device based on attributes such as indicated use, design, packaging, and materials.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document describes a comparison to a predicate device, not a performance study of the Koala Vascular Clamps and Inserts with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present in the provided document. This type of study is more relevant for diagnostic AI devices, not for surgical instruments like vascular clamps.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided document. This is not applicable to a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document. The basis for comparison is the characteristics and intended use of the legally marketed predicate device.
8. The sample size for the training set
This information is not present in the provided document. This is not applicable to a physical surgical instrument.
9. How the ground truth for the training set was established
This information is not present in the provided document. This is not applicable to a physical surgical instrument.
Summary of what is available:
The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) premarket notification. It aims to demonstrate that the "Koala Vascular Clamps and Inserts" are substantially equivalent to a legally marketed predicate device.
Predicate Device: Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - K951413
Comparison to Predicate Devices (which serves as the "study" for substantial equivalence):
| Attribute | Koala Clamps and Inserts | Baxter - V. Mueller Fogarty K951413 |
|---|---|---|
| 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 |
| 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 |
| Inserts provided sterile in Tyvek pouches | Yes | Yes |
| Clamps provided clean, non-sterile | Yes | Yes |
| Clamps - Stainless Steel | Yes | Yes |
| Inserts - polyurethane | Yes | Yes |
| Performance Standards / Specifications Required under Section 514 | None | None |
| Biocompatability tests for Class VI for the insert material | Yes | Yes |
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."
Conclusion of the FDA:
The FDA reviewed the 510(k) and determined that "the device is substantially equivalent... to legally marketed predicate devices."
This document does not provide a study with acceptance criteria for the Koala Vascular Clamps and Inserts themselves, but rather provides evidence for substantial equivalence to a known device, which is the basis for its regulatory clearance.
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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
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Non-Confidential Summary of Safety and Effectiveness
page 2 of ?
December 29, 1997
Comparison to Predicate Devices:
| Attribute | Koala Clampsand Inserts | Baxter -V. MuellerFogarty K951413 |
|---|---|---|
| Use | ||
| Indicated for clamping vesselsand total occlusion | Yes | Yes |
| Used in pulmonary, gastrointestinal,peripheral clamping, thoracicprocedures - occlusion of aorta,vena cava, cross clamping of aortaand aortic aneurysms, etc. | Yes | Yes |
| Intended to be reused | Yes | Yes |
| Design | ||
| Instruments manufactured by thesame company | Yes | Yes |
| Various sizes and configurationsoffered | Yes | Yes |
| Incorporate inserts to reduce traumaavailable in 33, 61 and 86 mm sizes | Yes | Yes |
| Packaging | ||
| Inserts provided sterile inTyvek pouches | Yes | Yes |
| Clamps provided clean,non-sterile | Yes | Yes |
| Materials | ||
| Clamps - Stainless Steel | Yes | Yes |
| Comparison to Predicate Devices: | ||
| Attribute | Koala Clampsand Inserts | Baxter -V. MuellerFogarty K951413 |
| Materials | ||
| Inserts - polyurethane | Yes | Yes |
| Performance Standards / Specifications | ||
| Required under Section 514 | None | None |
| Biocompatability tests for Class VIfor the insert material | Yes | Yes |
.
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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
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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
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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
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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
§ 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).