(349 days)
The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.
The KSEA Deployable Clamp is a manual surgical instrument for temporary cross occlusion of blood vessels. The body contact materials are surgical grade stainless steel.
The provided text is a 510(k) summary for the KSEA Deployable Vascular Clamp. This type of document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
Based on the information provided, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance is described in qualitative terms, asserting similarity to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in dimensions. | "dimensions... are similar." |
| Substantial equivalence to predicate device in performance. | "performance... are similar." |
| Substantial equivalence to predicate device in materials. | "stainless steel... are similar." |
| Substantial equivalence to predicate device in intended uses. | "intended uses are similar." |
| Device does not raise new issues of safety and effectiveness compared to predicate. | "The minor differences... raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." |
| Intended for temporary cross-occlusion of arteries and veins 0.3 - 1.6 cm in diameter. | The device is intended for this use. (This is an indication for use, not a performance metric directly, but implies the device can effectively occlude vessels within this range). |
| For use during endoscopic surgery. | The device is intended for this use. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary. A 510(k) submission typically focuses on comparison with a predicate, and detailed clinical study data with specific test sets and provenance might not be included in the summary if the device is deemed substantially equivalent based on design, materials, and intended use.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. As there's no mention of a formal clinical test set requiring expert adjudication for ground truth, this detail is absent.
4. Adjudication Method:
This information is not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
This information is not provided. The document makes no mention of a study involving human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This is not applicable. The KSEA Deployable Vascular Clamp is a manual surgical instrument, not an AI/algorithm-driven device.
7. Type of Ground Truth Used:
Ground truth, in the context of device performance, would typically involve direct measurement or observation of the device's ability to occlude vessels within the specified diameter range. However, the document relies on comparison to a predicate device for establishing safety and effectiveness, rather than presenting novel ground truth data from new studies. The "ground truth" used for approval is the existing safety and effectiveness profile of the predicate device.
8. Sample Size for the Training Set:
This information is not applicable as the device is a manual surgical instrument and does not involve machine learning algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
In summary: The provided 510(k) summary for the KSEA Deployable Vascular Clamp demonstrates that the device meets acceptance criteria through the principle of substantial equivalence to an existing predicate device. The "study" proving this involves a comparison of the new device's design, materials, and intended use with that of the predicate, concluding that any minor differences do not raise new issues of safety or effectiveness. Detailed clinical trials with specific performance metrics and ground truth establishment (as would be seen for a novel or AI-powered device) are not presented in this summary document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a close-up of a document with the words "Karl Storz Endoscopy" at the top. Below this, there is a large, bold number "K014277" printed across the page. At the bottom of the image, the date "DEC 11 2002" is visible, indicating the document's creation or processing date.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | James A. Lee, Ph.D.Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Vascular Clamp Forceps, and Endoscopic InstrumentTrade Name: (optional)The KSEA Deployable Vascular Clamp |
Indication: The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.
Device Description: The KSEA Deployable Clamp is a manual surgical instrument for temporary cross occlusion of blood vessels. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Deployable Vascular Clamp is substantially equivalent to the predicate device since dimensions, performance, stainless steel, and intended uses are similar. The minor differences between the Deployable Vascular Clamp and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Signature
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The text is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 11 2002
Karl Storz Endoscopy America c/o James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe 5th Floor Culver City, CA 90230
Re: K014277
Trade Name: KSEA Deployable Vascular Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: September 11, 2002 Received: September 12, 2002
Dear Dr. Lee:
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.
{2}------------------------------------------------
Page 2 -- James A. Lee, Ph.D.
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. 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) 594-4646. 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). 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,
O'Malley
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/13 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is in large, bold, white letters with a black circle in the middle of the "O". Below the word "STORZ" is the phrase "Karl Storz Endoscopy" in a smaller font. The background of the image is a grainy, black and white texture.
510(k) Number (if known): K014277
.
Device Name: KSEA Deployable Vascular Clamp
Indications for Use: The KSEA Deployable Vascular Clamp is intended for use by qualified surgeons for temporary cross-occlusion of arteries and veins ranging between 0.3 -1.6 cm in diameter during endoscopic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
X
OR Over-The-Counter Use:
(Per 21 CFR 801.109)
E'Mallis
Division of Cardiovascular & Respiratory Devices
510(k) Number K014277
(Optional Format 1-2-96)
§ 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).