(14 days)
No
The summary describes standard laparoscopic instruments for visualization and manipulation, with no mention of AI, ML, or advanced image processing beyond basic illumination and visualization.
Yes
The "Intended Use / Indications for Use" states that the device is used in "a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "access, illumination and visualization of internal structures...in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures." The "Device Description" also reinforces this by stating, "Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures."
No
The device description explicitly states it is a laparoscope and accessories, which are physical instruments used for surgical procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "access, illumination and visualization of internal structures and for manipulating soft tissue... in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures." This describes a surgical or procedural device used in vivo (within the body) for direct visualization and manipulation.
- Device Description: The description reinforces this by stating the device provides "illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures." Again, this points to a device used during a procedure on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples in vitro (outside the body), such as blood, urine, tissue, etc., which is the defining characteristic of an IVD.
Therefore, the Instrumed Laparoscopes and Accessories are surgical/endoscopic devices, not IVDs.
N/A
Intended Use / Indications for Use
Instrumed Laparoscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures.
Product codes
GEI, GCJ
Device Description
Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "K040855". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The number zero appears twice in the sequence.
APR 1 6 2004
Summary of Safety and Effectiveness
| 1. | Submission Applicant & Correspondent | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name:Instrumed International, INC.Address:626 Cooper Court | |||||||||||||
| Schaumburg, IL 60173Phone:847-908-0292Fax:847-908-0293Mail:jwalsh@instrumedinc.bizContact person:Jim Walsh | Name: | Instrumed International, INC. | Address: | 626 Cooper Court | |||||||||
| Schaumburg, IL 60173 | Phone: | 847-908-0292 | Fax: | 847-908-0293 | Mail: | jwalsh@instrumedinc.biz | Contact person: | Jim Walsh | |||||
| Name: | Instrumed International, INC. | ||||||||||||
| Address: | 626 Cooper Court | ||||||||||||
| Schaumburg, IL 60173 | |||||||||||||
| Phone: | 847-908-0292 | ||||||||||||
| Fax: | 847-908-0293 | ||||||||||||
| Mail: | jwalsh@instrumedinc.biz | ||||||||||||
| Contact person: | Jim Walsh | ||||||||||||
| 2. | Device name & Classification panel | ||||||||||||
| Trade nameLaparoscope & Monopolar | |||||||||||||
| laparoscopic instrumentsCommon name:Laparoscope & AccessoriesClassification:876.1500 | Trade name | Laparoscope & Monopolar | |||||||||||
| laparoscopic instruments | Common name: | Laparoscope & Accessories | Classification: | 876.1500 | |||||||||
| Trade name | Laparoscope & Monopolar | ||||||||||||
| laparoscopic instruments | |||||||||||||
| Common name: | Laparoscope & Accessories | ||||||||||||
| Classification: | 876.1500 | ||||||||||||
| 3. | Substantial Equivalence | ||||||||||||
| Substantial Equivalence is claimed to the following devices | |||||||||||||
| Gimmi Laparoscope | |||||||||||||
| Manufactured by | |||||||||||||
| Gimmi GmbH | |||||||||||||
| Registered in the FDA Database under the following number: K012660 |
:
1
| Description of device
Instrumed Laparoscopes provide illumination and visualization in diagnostic
procedures and in conjunction with laparoscopic instruments (accessories) operative
| laparoscopic procedures | ||||||
|---|---|---|---|---|---|---|
| and the control control of the control of the control of | ||||||
| 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 | ||||||
| and the control control control controlled in the controlled | ||||||
- 11:4
2
| 5. | Intended Use & Indications |
|---|---|
| Instrumed Laparoscopes and Accessories are intended to be used by qualified | |
| physicians to provide access, illumination and visualization of internal structures | |
| and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and | |
| suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed | |
| and minimally invasive procedures. |
:
.
:
:
3
| 6. | Technical Comparison |
|---|---|
| The Instrumed product is similiar to the Gimmi product in terms of design and technical characteristics. The Laparoscope and the respective laparoscopic instruments are identical to the Gimmi products. | |
| The Instrumed product is also similiar to the Gimmi products in terms of the used material. | |
| In terms of performance data, the presented data that was conducted on the Instrumed instruments shows in its results that the Laparoscope and the laparoscopic instruments are absolutely safe and effective for its intended use and do not raise any questions regarding safety and effectiveness. |
:
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Instrumed International, Inc. c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K040855
Trade/Device Name: Instrumed Laparoscopes and Accessories Regulation Number: 21 CFR 878.4400, 876.1500 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Endoscope and accessories Regulatory Class: II Product Code: GEI, GCJ Dated: March 25, 2004 Received: April 2, 2004
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate devices marketed in interstate for ass saled in the encreased in 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 (sce above) into either class II (Special Controls) or class III (PMA), it rr your device 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.
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Mr. Stefan Preiss
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma let notification. The FDA finding of substantial equivalence of your device to a legally promatics notificated with 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) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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
Sincercly yours,
Sincerely yours,
Mark M. Millburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): _
Device Name: Instrumed Laparoscopes and Accessories
Indications for Use:
Instrumed Laparoscopes and Accessories are intended to be used by qualified physicians to provide access, illumination an i visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and herapeutic laparoscopic/urologic closed and minimally invasive procedures.
Mark N. Millican
Division of General, Restorative, and Neurological Devices
510(k) Number KC40855
Prescription Use
(Part 21 CFR 801 Subpart D)
ANI /OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW TH S LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Off ce of Device Evaluation (ODE)