(349 days)
Not Found
Not Found
No
The summary describes a manual surgical instrument with no mention of AI, ML, or any related concepts like image processing or data analysis.
No.
The device is a surgical instrument used for temporary occlusion of blood vessels during surgery, not for treating a disease or condition.
No
The device is described as a "Deployable Vascular Clamp" for "temporary cross-occlusion of arteries and veins" during surgery. Its function is to occlude blood vessels, which is an interventional or therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "manual surgical instrument" made of "surgical grade stainless steel," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary cross-occlusion of blood vessels during surgery. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a "manual surgical instrument."
- 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 perform any such analysis.
Therefore, the KSEA Deployable Vascular Clamp is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries and veins ranging between 0.3 -1.6 cm in diameter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons / endoscopic 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.
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
§ 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 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 Drive
Culver 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 Instrument
Trade 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)