(175 days)
Not Found
No
The device description and performance studies focus on mechanical function (vacuum pressure) and biocompatibility, with no mention of AI or ML.
No
The device aids in a surgical procedure by creating space for needle insertion, but it does not treat or prevent a disease, nor does it affect the structure or function of the body in a therapeutic way.
No
The device is an access device intended to create space for the insertion of a Veress needle during laparoscopic procedures, not to diagnose a medical condition.
No
The device description clearly states it is a "sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle." This describes physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LevaLap Function: The LevaLap Laparoscopic Access Device is a surgical tool used externally on the abdominal wall to create space for surgical access. It does not analyze any biological samples.
The description clearly indicates its purpose is to aid in a surgical procedure by physically manipulating the abdominal wall using negative pressure. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
Product codes
HIF
Device Description
The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access. The device includes a vacuum bypass plug positioned in the vacuum intake port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peri-umbilical region of the abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room (OR)
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)
Non-clinical testing was conducted to verify that the LevaLap Laparoscopic Access Device performs as intended. The following non-clinical bench tests were performed successfully on the Levalap Laparoscopic Access Device: vacuum draw and vacuum hold; biocompatibility according to ISO 10993-1 and the related FDA Guidance; shelf-life testing for package integrity, vacuum draw, and vacuum hold.
Under simulated use conditions, the device maintains consistent negative pressure at -0.8 Bar for a minimum of 1 minute, with a 14G needle inserted in the septum.
In addition, validation activities included sterilization, package integrity, shelf life and biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 23, 2022
Core Access Surgical Technologies, Inc. Marianne D. Jacklyn Director of Regulatory Affairs 3495 Piedmont Road, NE Building 11, Suite 905 Atlanta. GA 30305
Re: K212786 Trade/Device Name: LevaLap Laparoscopic Access Device Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: January 5, 2022 Received: January 10, 2022
Dear Marianne D. Jacklyn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212786
Device Name LevaLap Laparoscopic Access Device
Indications for Use (Describe)
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
General Information 1
Submitter Core Access Surgical Technologies, Inc. 3495 Piedmont Road, Building 11, Suite 905 Atlanta, GA 30305 USA
Contact Person Marianne D. Jacklyn, Director of Regulatory Affairs mjacklyn@castlap.com +1 (503) 729-9633
Date prepared 2
February 17, 2022
Device Information ന
| Trade Name | LevaLap Laparoscopic Access Device |
|---|---|
| Common Name | Laparoscopic insufflator |
| Classification Number | 21 CFR 884.1730 |
| Classification Name | Laparoscopic insufflator |
| Product Code | HIF |
| Product Code Name | Insufflator, Laparoscopic |
| Regulatory Class | II |
Predicate Device র্ব
Predicate Device Aragon Surgical LapCap (K073452)
The predicate device has not been subject to a design related recall.
Device Description ട്
The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphereshaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access.
4
Indications for Use റ
The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
7 Comparison of Technological Characteristics
The subject and predicate devices have the same intended use and principle of operation, using mechanical force applied via negative pressure to lift the abdominal wall. Both devices consist of a round-shaped housing with an entry point for a Veress needle, and a vacuum intake port to connect to standard vacuum systems. Technological differences are limited to different materials of construction, septum/disc compression design, and the vacuum bypass plug component of the subject device. These differences do not raise different questions of safety and effectiveness.
The subject device has established performance specifications to support its intended use, with testing to demonstrate that these specifications are met. In addition, the finished subject device underwent biocompatibility testing for cytotoxicity, sensitization and irritation, in accordance with ISO 10993-1 and the FDA Guidance on use of this standard.
The subject device includes a vacuum bypass plug positioned in the vacuum intake port. This component is designed to prevent abdominal tissue prolapsing into the vacuum intake port.
In addition to the simulated use testing described below, validation activities for the subject device also included sterilization, packaging integrity and shelf-life testing.
| Table 1. Device Comparison | |||
|---|---|---|---|
| Description | Subject Device | Predicate Device (K073452) | |
| Indications for | |||
| use | The LevaLap Laparoscopic Access Device | ||
| is intended for use in the peri-umbilical | |||
| region of the abdominal wall prior to the | |||
| establishment of a pneumoperitoneum to | |||
| aid in the insertion of a Veress needle | |||
| during gynecologic (pelvic) and general | |||
| surgical (intra-abdominal) laparoscopic | |||
| procedures. | The Aragon Surgical LapCap is intended | ||
| for use in the peri-umbilical region of | |||
| the abdominal wall with a Veress | |||
| needle for the establishment of a | |||
| pneumoperitoneum during gynecologic | |||
| (pelvic) and general surgical | |||
| (intraabdominal) laparoscopic | |||
| procedures. | |||
| Description | The LevaLap Laparoscopic Access Device | ||
| is a sterile single-use device, consisting of | |||
| a clear hemisphere-shaped housing | |||
| containing a port for connection to a | |||
| standard operating room (OR) vacuum | |||
| system and a septum for introduction of a | |||
| Veress needle. The device includes a | |||
| vacuum bypass plug positioned in the | |||
| vacuum intake port. | The Aragon Surgical LapCap is a single- | ||
| use device used during laparoscopic | |||
| surgical procedures. The device consists | |||
| of a bell-shaped polycarbonate dome | |||
| housing containing a pass-through port | |||
| for introduction of a standard Veress | |||
| needle and a vacuum port for | |||
| attachment to a standard hospital | |||
| vacuum line. |
Please refer to Table 1 below for a detailed technological comparison.
5
| Table 1. Device Comparison | ||
|---|---|---|
| Description | Subject Device | Predicate Device (K073452) |
| Principle of | ||
| operation | Mechanical force is applied by applying | |
| vacuum and introducing a negative | ||
| pressure onto the surface of patient's | ||
| abdomen, to lift the abdominal wall. | Mechanical force is applied by applying | |
| vacuum and introducing a negative | ||
| pressure onto the surface of patient's | ||
| abdomen, to lift the abdominal wall. | ||
| Materials | Styrene-butadiene copolymers (SBC) | |
| Thermoplastic elastomer (TPE) | Polycarbonate | |
| No other materials are known | ||
| Performance | ||
| Specifications | Under simulated use conditions, the | |
| device maintains consistent negative | ||
| pressure at -0.8 Bar for a minimum of | ||
| 1 minute, with a 14G needle inserted in | ||
| the septum. | Unknown | |
| Testing | The subject device underwent | |
| representative functional testing against | ||
| specified requirements for vacuum draw | ||
| and vacuum hold at T=0 and after | ||
| accelerated aging simulating 2 years. |
In addition, validation activities included
sterilization, package integrity, shelf life
and biocompatibility testing. | Unknown |
Non-Clinical Performance 8
Non-clinical testing was conducted to verify that the LevaLap Laparoscopic Access Device performs as intended. The following non-clinical bench tests were performed successfully on the Levalap Laparoscopic Access Device: vacuum draw and vacuum hold; biocompatibility according to ISO 10993-1 and the related FDA Guidance; shelf-life testing for package integrity, vacuum draw, and vacuum hold.
ഗ Conclusion
The subject and predicate devices have the same intended use and similar technological characteristics. The differences in technological characteristics do not raise different questions of safety or effectiveness. Performance testing conducted on the subject device demonstrate that it is as safe and effective as the predicate device to support substantial equivalence.