(124 days)
Not Found
No
The device description and performance studies focus on a purely mechanical, manually operated surgical instrument with no mention of computational or data-driven capabilities.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during laparoscopic procedures. It does not actively treat or cure a disease or condition.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during laparoscopic procedures. Its function is to physically interact with tissue, not to diagnose conditions or process diagnostic information.
No
The device description clearly states it is a reusable, non-energized, stainless steel surgical instrument with physical components (handle, shaft, end effector) and describes manual manipulation. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "grasp, clamp, and manipulate soft tissues" during laparoscopic procedures. This is a surgical function performed on the patient's body.
- Device Description: The description details a surgical instrument used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with tissues within the body during surgery.
N/A
Intended Use / Indications for Use
The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various soft tissues accessible during laparoscopic procedures
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)
Pre-clinical evaluation of the device was performed to ensure the device may be used as designed. The Standard Clamp was used in a live anesthetized pig to evaluate the ability to clamp on tissue without damaging tissue as compared to other laparoscopic graspers and clamps were placed on the porcine stomach laparoscopically. Tissue effects were observed in vivo during clamping and after release. After clamping, the stomach was resected and histology samples were analyzed for each clamp.
Testing demonstrated acceptable performance of the Standard Clamp. No damage to surrounding tissues were caused by any of the clamps. There histology demonstrated similar types of tissue effects between the three clamps. The data demonstrate conformance to the device specifications.
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.
Standard Bariatrics Standard Clamp – K153358, Aesculap Inc. Manual Laparoscopic Instruments – K944467
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
§ 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.
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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 caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
Standard Bariatrics Ms. Alison Sathe Director of Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242
Re: K161720
Trade/Device Name: Standard Clamp Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 31, 2016 Received: September 6, 2016
Dear Ms. Sathe:
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 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 devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161720
Device Name Standard Clamp
Indications for Use (Describe)
The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The word "BARIATRICS" has a trademark symbol next to it.
510(K) Summary
This 510(K) Summary of safety and effectiveness for the Standard Clamp is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Standard Bariatrics |
|---|---|
| Address: | Standard Bariatrics |
| 4362 Glendale Milford Road | |
| Cincinnati, OH 45242 USA | |
| Contact Person: | Alison Sathe |
| Director of Regulatory Standard Bariatrics | |
| Telephone/Email/Fax: | 513-304-7971 |
| alison@standardbariatrics.com | |
| Preparation Date: | June 16, 2016 |
| Device Trade Name: | Standard Clamp |
| Common Name: | Laparoscopic Surgical Instrument |
| Classification Name: | Endoscope and accessories (GCJ, 21 CFR 876.1500) |
| Legally Marketed Predicate Device(s): | Standard Bariatrics Standard Clamp – K153358 |
| Aesculap Inc. Manual Laparoscopic Instruments – K944467 |
Device Description:
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
Intended Use:
The Standard Clamp is a hand held device used during laparoscopic surgery to clamp long planes of soft tissues. The device allows the surgeon to clamp and manipulate flat tissue and organs, such as the stomach. The clamp can also be used by the surgeon to help guide endoscopic staplers during resection of tissue.
Indication for Use:
The Standard Clamp is indicated for use in laparoscopic procedures to facilitate grasping, mobilization, and transection of tissue.
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Image /page/4/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a stylized red "S" on the left, followed by the words "STANDARD BARIATRICS" in black, block letters. The "S" is made up of three curved lines that form a square shape.
Technological Characteristics:
The Standard Clamp is a non-energized, manually articulated, laparoscopic clamp. The device is comprised of stainless steel and is validated for sterilization by steam autoclave. Two knobs on the device handle allow the user to adjust the angle of the end effector with respect to the shaft and open/close the jaws.
Table 1: Technological Characteristics
| Product | Standard Clamp
(proposed) | Standard Clamp
(K153358) | Aesculap Manual
Laparoscopic Instruments
(K944467) |
|--------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------|
| Type of Device | Reusable | Reusable | Reusable |
| Materials (end effector) | Stainless Steel | Stainless Steel | Stainless Steel |
| Length (Overall) | 25.4 inches (64.5 cm) | 25.4 inches (64.5 cm) | unknown |
| Length (end effector) | 10.6 inches (27 cm) | 10.6 inches (27 cm) | 4 inches (10 cm) |
| Width of end effector | 0.4 inches (1 cm) | 0.4 inches (1 cm) | 0.4 inches (1 cm) |
| Weight | 1.7 lbs. | 1.7 lbs. | 1 lb. |
| Articulation Mechanism | Rotating knob on handle | Rotating knob on handle | Rotating knob on handle |
| Articulation | up to 55° from midline | up to 55° from midline | up to 45° from midline |
| End effector design | Stainless steel jaws with
non-piercing ridges to
grasp tissue | Stainless steel jaws with
non-piercing ridges to
grasp tissue | Stainless steel jaws
without ridges to grasp
tissue |
| End effector closure | Parallel closure | Parallel closure | Scissor-type closure |
| Handle | In-line grip | In-line grip | Pistol grip |
| Sterilization Method | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| Flush Port? | Yes | Yes | Unknown |
| Anatomical Site Used | Various soft tissues
accessible during
laparoscopic procedures | Various soft tissues
accessible during open
procedures | Various soft tissues
accessible during
laparoscopic procedures |
| Types of procedures | Laparoscopic procedures | Open procedures | Laparoscopic procedures |
| Energy Delivered? | No | No | No |
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Image /page/5/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a red square with a stylized white "S" inside. To the right of the square is the company name, "STANDARD BARIATRICS," in bold, black letters. The trademark symbol is located to the right of the company name.
| Compatible with 12 mm
| trocar? | Yes | Yes | Yes |
|---|---|---|---|
| Biocompatibility | Biocompatible for | ||
| blood/bone/tissue | |||
| contact for limited | |||
| duration | Biocompatible for | ||
| blood/bone/tissue | |||
| contact for limited | |||
| duration | Biocompatible for | ||
| blood/bone/tissue | |||
| contact for limited | |||
| duration |
Performance Data:
Pre-clinical evaluation of the device was performed to ensure the device may be used as designed. The Standard Clamp was used in a live anesthetized pig to evaluate the ability to clamp on tissue without damaging tissue as compared to other laparoscopic graspers and clamps were placed on the porcine stomach laparoscopically. Tissue effects were observed in vivo during clamping and after release. After clamping, the stomach was resected and histology samples were analyzed for each clamp.
Testing demonstrated acceptable performance of the Standard Clamp. No damage to surrounding tissues were caused by any of the clamps. There histology demonstrated similar types of tissue effects between the three clamps. The data demonstrate conformance to the device specifications.
Substantial Equivalence:
The Standard Clamp has the same indications, technological characteristics, principles of operation as its predicate devices. There are no new issues of safety or effectiveness. Thus, the Standard Clamp is substantially equivalent to the predicate devices.