(209 days)
Not Found
Not Found
No
The summary describes traditional surgical instruments for mechanical manipulation of blood vessels and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The devices are surgical tools for temporary occlusion, cutting, and suturing, not for treating a condition or disease.
No
Explanation: The provided text describes the Aesculap's Vascular Clamps and Instruments as tools for temporary occlusion, cutting, dissecting, clamping, fixation, and suturing of blood vessels during surgical procedures. There is no mention of these devices being used to identify or analyze diseases, conditions, or impairments. Their function is purely interventional/surgical.
No
The device description explicitly lists physical instruments like vascular clamps, flexible trocars, scissors, forceps, and needleholders, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used during surgical procedures to manipulate blood vessels and other structures. This is a direct surgical intervention, not a test performed on samples taken from the body.
- Device Description: The description lists surgical instruments like clamps, trocars, scissors, and forceps. These are tools used for physical manipulation during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are surgical tools used on the body during a procedure.
N/A
Intended Use / Indications for Use
Aesculap's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surgical approach.
Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.
Product codes (comma separated list FDA assigned to the subject device)
DXC, KOG, GCJ
Device Description
The Vascular Instruments consist of vascular clamps, flexible trocars, and various endoscopic vascular instruments (scissors, forceps, clamps).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, surgical site
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)
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
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
510(k) Premarket Notification
Aesculap Vascular Instruments
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
AESCULAP VASCULAR INSTRUMENTS
June 17. 1999
Contact
Company
Aesculap®, Inc.
1000 Gateway Blvd.
So. San Francisco, CA 94080
Mary Ellen Holden, Senior Requlatory Associate 650-624-5072 Phone: FAX: 650-589-3007
Trade Name
Aesculap Vascular Instruments
Common Name
Vascular Clamps, Endoscopic instruments, trocars
Classification Name and Product Code
Vascular Clamps Endoscope and Accessories 74DXC 78 KOG
Product Classification
Class II
Requiatory Classification
21 CFR Section 876.1500 21 CFR Section 870.4450
Endoscope and Accessories Vascular Clamp
Intended Use
Aescular's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surgical approach.
Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surqical site for use in laparoscopic vascular surgery.
(. (' 0 4
1
Page 2 of 2
005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
AESCULAP VASCULAR INSTRUMENTS
Device Description
The Vascular Instruments consist of vascular clamps, flexible trocars, and various endoscopic vascular instruments (scissors, forceps, clamps).
Summary of Technological Characteristics
Aesculap currently markets a complete vascular product line, which includes vascular clamps and instruments. In addition, Aesculap markets a complete endoscopic product line that includes endoscopes, flexible and rigid trocars, endoscopic clip appliers and endoscopic instruments such as forceps and scissors. The expanded line of Vascular Clamps and Endoscopic Vascular Instruments included in this submission do not impart any new technological characteristics. They use the same technology as current vascular and laparoscopic product lines - the only difference is the surgical application.
Performance Data
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Substantial Equivalence
Aesculap believes that the Vascular Instruments presented in this submission are substantially equivalent in design, function, and intended use to currently marketed vascular and endoscopic devices from companies such as:
- Aesculap .
- Codman .
- Heartport .
- Mueller .
- Walter Lorenz ●
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is in black and white and appears to be of moderate resolution.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Ms. Mary Ellen Holden Senior Regulatory Associate Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080
K992053 Re : Aesculap Vascular Instruments Trade Name: Requlatory Class: II Product Code: DXC and GCJ October 14, 1999 Dated: October 15, 1999 Received:
Dear Ms. Holden:
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 to 895. A substantially equivalent determination assumes compliance 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 assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation .
3
Page 2 - Ms. Mary Ellen Holden
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) 594-4586. 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 vour 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".
.gov, CA.IT, GO.MA, GO.MA.IT, IT.CM
Sincerely yours,
Chitopher for.
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
Aesculap Vascular Instruments
Page 1 of 1
INDICATION FOR USE STATEMENT
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------第一次 - 1998年
510(k) Number (if known):
K992c53
Device Name:
Aesculap Vascular Instruments
Indication for Use:
Aesculap's Vascular Clamps and Instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surqical approach.
Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chit for Witten
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K992053 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
or
| Over-the-Counter Use | |
|---|---|
| ---------------------- | -- |