(58 days)
Not Found
No
The description focuses on the mechanical function and physical components of the surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as surgical instruments used to grasp, hold, and manipulate tissues, which are tools for a procedure, not a device that directly treats a condition or disease.
No
The device is described as a surgical tool used to grasp, hold, and manipulate soft internal tissues and other items during pediatric surgery. Its function is to aid in surgical procedures, not to diagnose conditions.
No
The device description clearly details physical instruments (clamps, needles, handles) used for surgical procedures, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures (penetrating soft tissue, grasping, holding, and manipulating tissues and items like hernia mesh) within the human body.
- Device Description: The description details a surgical instrument with a needle, jaws, and a clamping system, designed for direct interaction with internal tissues during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Product codes
OCW, KOG, HET, KOA, FBO
Device Description
The MNI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices intended for pediatric surgery. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babook clamp, bowel clamp, and hernia clamp. The device includes a selfsching safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip.
The device is provided in the following configurations:
Length: 150mm, Clamp Type: Bowel Clamp
Length: 150mm, Clamp Type: Babcock Clamp
Length: 150mm, Clamp Type: Hernia Clamp
The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, certain areas of the human anatomy
Indicated Patient Age Range
pediatric
Intended User / Care Setting
physician
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)
The subject device has been subjected to and passed a variety of mechanical tests and evaluations. The device is composed of biocompatible materials with a history of usage in the medical device industry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951173, K062326, K062326, K012007 / K992904
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mini Lap Technologies, Inc. % Mr. Joseph Azary Azary Technologies, LLC 543 Long Hill Avenue Shelton, CT 06484
JUL 2 7 2015
Re: K070352
Trade/Device Name: MINI LAP Pediatric Instruments with Medusa Clamping System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE Itr): January 13, 2007 Received (Date on orig SE ltr): February 28, 2007
Dear Mr. Azary,
This letter corrects our substantially equivalent letter of April 5, 2007.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
1
Page 2 -
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K070352_
Device Name: MINI LAP Pediatric Instruments with Medusa Clamping System
Indications For Use:
The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office(Division Evaluation (ODE)
Division of General, Restorative,
and Neurological DevicesPage 1 of 1
510(k) Number L070382
Page 4
3
APR 5 - 2007
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)] January 31, 2007
Submitter's Information [21 CFR 807.92(a)(1)]
Regulatory Contact Joseph Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317 Email: info@azarytech.com
Sponsor / Manufacturer Mini Lap Technologies Inc. 88 Ashford Avenue Dobbs Ferry, NY 10522
Tel: 914 591 8400
FDA Establishment Registration is pending.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name
- MINI LAP Pediatric Instruments with Medusa Clamping System .
Device Common, Usual, or Classification Names
- Grasping Instruments, Laparoscopic Instruments, Graspers, Cannula, Trocar, Manual Surgical In o struments
Page 7-1
4
Classification Panel
- Classification of this device would fall under the responsibility of the Gastroenterology / Urology o panel.
Class
Based on our research as well as the 513(g) letter from FDA we believe the device is a class 2 device classified under the following Product Codes:
- KOG, 21 CFR 876.1500, Endoscope Accessories o
- HET, 21 CFR 884.1720, Gynecological Laparoscope Accessories o
- KOA, 21 CFR 876.4730 Manual Surgical Instruments o
- FBO. 21 CFR 878.5090 Trocar O
Predicate Device [21 CFR 807.92(8)(3)]
- U.S. Surgical Corp MiniSite 2mm Laparoscopic Instruments K951173 o
- U.S. Surgical Corp MiniPort 2mm K062326* O
- U.S. Surgical Corp Versaport trocar with fixation sleeve K062326 0
- Stryker Pediatric Surgical Instruments Class 1 devices exempt from 510(k) 0
- Taut Adapt Pediatric Access Ports K012007 / K992904 0
Description of the Device [21 CFR 807.92(a)(4)]
The MNI LAP Pediatric Instruments with MEDUSA Clamping system are a family of minimally invasive devices intended for pediatric surgery. The devices penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Prior to insertion, the physician must depress the safety button and retract the instrument into the needle. The needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the jaws of the instrument will open. The instrument will be offered in various configurations including babook clamp, bowel clamp, and hernia clamp. The device includes a selfsching safety that prohibits the jaws from returning to their fully retracted position while in use, which acts as a blunt shield for the sharp needle tip.
Page 7-2
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5
The device is provided in the following configurations:
Length | Clamp Type |
---|---|
150mm | Bowel Clamp |
150mm | Babcock Clamp |
150mm | Hernia Clamp |
The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use ..
Intended Use [21 CFR 807.92(a)(5)]
The MNI LAP Pediatic Instruments with MEDUSA Clamping system are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh, during pediatric surgery.
Technological Characteristics [21 CFR 807.92(a)(6)]
We believe the MINI LAP Pediatric instruments are substantially equivalent to the predicate devices.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed a variety of mechanical tests and evaluations. Addition-I he device is composed of biocompatible materials with a history of usage in the medical device industry.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
Page 7-3
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