(14 days)
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.
Instrumed Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures
This document describes a 510(k) premarket notification for Instrumed Laparoscopes and Accessories. The submission claims substantial equivalence to a predicate device, the Gimmi Laparoscope (K012660). Therefore, the study details you are asking for, which typically involve demonstrating performance against defined acceptance criteria, are not directly presented as they would be for a novel device requiring such proof.
Instead, the submission relies on demonstrating technical similarity and that the Instrumed instruments are "absolutely safe and effective for its intended use and do not raise any questions regarding safety and effectiveness" based on performance data conducted on the Instrumed instruments. However, the specific details or content of this "performance data" are not provided in this summary.
Given the nature of a 510(k) submission seeking substantial equivalence to a predicate device, a formal study demonstrating a device meets a specific set of acceptance criteria with detailed statistical analysis and power calculations, as you might expect for a new technology, is generally not required in the same way. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, many of the specific questions about sample size, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable or not explicitly provided in this summary document focused on substantial equivalence.
Here's an attempt to address your questions based on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Summary Statement) |
|---|---|
| Equivalence in Design and Technical Characteristics to Gimmi Laparoscope (K012660) | The Instrumed product is similar to the Gimmi product in terms of design and technical characteristics. The Laparoscope and the respective laparoscopic instruments are identical to the Gimmi products. |
| Equivalence in Materials Used to Gimmi Laparoscope (K012660) | The Instrumed product is also similar to the Gimmi products in terms of the used material. |
| Safety and Effectiveness for Intended Use | "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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "presented data that was conducted on the Instrumed instruments."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. A formal expert-driven ground truth establishment for a test set is not described as part of this substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (laparoscopes and accessories), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. The "performance data" would likely have involved engineering tests, material testing, and potentially some form of clinical observation or simulated use, but the nature of the "ground truth" (e.g., benchmark values, successful function, lack of adverse events) is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. This is not a machine learning or AI device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified as there is no "training set" described.
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APR 1 6 2004
Summary of Safety and Effectiveness
| 1. | Submission Applicant & Correspondent | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name:Instrumed International, INC.Address:626 Cooper CourtSchaumburg, IL 60173Phone:847-908-0292Fax:847-908-0293Mail:jwalsh@instrumedinc.bizContact person:Jim Walsh | Name: | Instrumed International, INC. | Address: | 626 Cooper CourtSchaumburg, 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 CourtSchaumburg, 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 & Monopolarlaparoscopic instrumentsCommon name:Laparoscope & AccessoriesClassification:876.1500 | Trade name | Laparoscope & Monopolarlaparoscopic instruments | Common name: | Laparoscope & Accessories | Classification: | 876.1500 | |||||||
| Trade name | Laparoscope & Monopolarlaparoscopic instruments | ||||||||||||
| Common name: | Laparoscope & Accessories | ||||||||||||
| Classification: | 876.1500 | ||||||||||||
| 3. | Substantial Equivalence | ||||||||||||
| Substantial Equivalence is claimed to the following devicesGimmi LaparoscopeManufactured byGimmi GmbHRegistered in the FDA Database under the following number: K012660 |
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| Description of deviceInstrumed Laparoscopes provide illumination and visualization in diagnosticprocedures and in conjunction with laparoscopic instruments (accessories) operativelaparoscopic 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 | ||||||
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| 5. | Intended Use & Indications |
|---|---|
| Instrumed Laparoscopes and Accessories are intended to be used by qualifiedphysicians to provide access, illumination and visualization of internal structuresand for manipulating soft tissue (grasping, cutting, coagulating, dissecting, andsuturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closedand minimally invasive procedures. |
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| 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.
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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
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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)
§ 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.