(112 days)
Not Found
No
The device description focuses on mechanical features and instrument manipulation, with no mention of AI or ML capabilities.
No.
The device is described as an instrument to facilitate surgical access during minimally invasive abdominal laparoscopic surgery, not to perform a therapeutic function itself. It creates a path of entry and allows instruments to pass through, but does not diagnose, cure, mitigate, treat, or prevent disease.
No
The device is described as facilitating multi-instrument access during laparoscopic surgical procedures by providing a path of entry for laparoscopic instruments. It is used to perform surgery, not to diagnose a condition.
No
The device description clearly outlines a physical, single-use surgical instrument with multiple channels, flexible and rigid components, and ports for insufflation. It also includes a physical support arm accessory. The performance studies focus on biocompatibility, sterility, functionality, and mechanical strength of the physical components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the SPIDER™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery." This describes a surgical access device used during a surgical procedure on a patient.
- Device Description: The description details a multi-channel cannula for facilitating instrument access into the abdomen for surgery. It mentions insufflation, smoke evacuation, and maintaining pneumoperitoneum, all related to surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
The SPIDER™ is clearly a surgical instrument designed for use in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The SPIDER™ (Single Port Instrument Delivery Extended Reach) is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The SPIDER™ is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. Following a Hasson cut down incision, the multi-channel cannula is inserted through a small abdominal incision. The channels are deployed allowing laparoscopic instruments to pass through each channel into the abdomen to perform laparoscopic surgery. Two channels known as IDTs (Instrument Delivery Tubes) are positioned east to west and include extended lumens to facilitate manipulation of flexible surgical instruments, enabling control of the instruments over extended distances. These 2 IDTs are flexible and allow for x, y, and z motion for a multidirectional approach of the surgical field, mimicking the approach of standard laparoscopic surgery. Two (2) rigid channels, north to south, can accommodate an endoscope or a rigid surgical instrument. The device includes ports for insufflation or smoke evacuation. Pneumoperitoneum is maintained in the abdomen during the surgical procedure. The single use SPIDER™ device is provided pre-sterilized and is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
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)
Verification and validation studies were conducted for the SPIDER™ to demonstrate biocompatibility, sterility, and functionality. Pre-clinical studies were conducted to demonstrate equivalency to the medical effect achieved with standard multiple incision laparoscopic surgery and to validated the intended use of the device. The Support Arm was tested to validate cleaning and autoclaving cycles. The Support Arm was also tested for retention strength, mechanical strength under simulated use, and functionality following repeated use.
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.
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.
0
Ko90902
P1 of 3
510(k) Summary - K090902
This summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: June 26, 2009
JUL 2 2 2009
-
- Submitter:
":
- Submitter:
Submitted by:
TransEnterix. Inc. 3908 Patriot Drive, Suite 170 Durham, NC 27703
TEL: 919-541-9977 FAX: 919-541-9978
Contact:
Tammy Carrea Director, Regulatory Affairs and Quality Assurance
-
- Device:
SPIDER TM Single Port Surgical Device Propriety Name Common Name Laparoscopic instrument and accessory Classification Name: Endoscope and accessories Classification: Class II 21 CFR 876.1500 Product Code: GCJ
- Device:
3. Predicate Device:
Covidien, SILS Port - K082619 Endopath III Bladeless Trocar - K032676
4. Description:
The SPIDER™ is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures.
Following a Hasson cut down incision, the multi-channel cannula is inserted through a small abdominal incision. The channels are deployed allowing laparoscopic instruments to pass through each channel into the abdomen to perform laparoscopic surgery.
Two channels known as IDTs (Instrument Delivery Tubes) are positioned east to west and include extended lumens to facilitate manipulation of flexible surgical instruments, enabling control of the instruments over extended distances. These 2 IDTs are flexible and allow for x, y, and z motion for a multidirectional approach
1
Ko 90902
Pz. B 3
of the surgical field, mimicking the approach of standard laparoscopic surgery. Two (2) rigid channels, north to south, can accommodate an endoscope or a rigid surgical instrument. The device includes ports for insufflation or smoke evacuation. Pneumoperitoneum is maintained in the abdomen during the surgical procedure. The single use SPIDER™ device is provided pre-sterilized and is a single use device.
5. Indications for Use:
្នូ រ
The SPIDER™ (Single Port Instrument Delivery Extended Reach) is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery.
6. Comparison of Technological Characteristics with Predicate:
The SPIDER™ Device has the same intended use and function of other currently marketed single port access devices and single port trocars in that it is intended to establish a path of entry for laparoscopic instruments in minimally invasive abdominal procedures. Like the single port predicates it achieves this function via a single port and single incision. The device has the same main port and channel dimensions and similarly employs a similar number of rigid and flexible ports like the predicates. Like the predicate devices it includes valves to maintain pneumoperitoneum and insufflation ports and stopcocks to achieve insufflation and smoke evacuation. Similar to the predicate devices it is provided pre-sterilized, is disposable, and is a single use device, the same as other predicate devices.
It incorporates the same design features as the predicates to facilitate minimally invasive surgical procedures. It has multiple channels to facilitate introduction of numerous surgical instruments. It may be inserted using a Hasson technique under direct visualization. It has IDTs to allow placement. control and manipulation of rigid and flexible surgical instruments.
The IDTs, while longer than the channels of the predicate devices, are not longer than the effective length of surgical instruments and are presented and positioned within the surgical space in a similar manner. The IDTs are able to achieve triangulation in a manner similar to that of standard multi-port laparoscopic equipment.
The SPIDER™ device also includes a Support Arm accessory. The support arm is provided to mount and stabilize the device. The support arm has been tested for mechanical stability, strength, and repeated use and found to be adequate to stabilize and maintain the SPIDER™ device in a fixed position during surgical procedures.
2
Ko-90902
Image /page/2/Picture/1 description: The image shows the handwritten text "P3 83". The text is written in a cursive style with a black ink. The number 3 is written twice, once after the letter P and once after the number 8. There is a line under the number 83.
7. Performance Data:
Verification and validation studies were conducted for the SPIDER™ to demonstrate biocompatibility, sterility, and functionality. Pre-clinical studies were conducted to demonstrate equivalency to the medical effect achieved with standard multiple incision laparoscopic surgery and to validated the intended use of the device.
The Support Arm was tested to validate cleaning and autoclaving cycles. The Support Arm was also tested for retention strength, mechanical strength under simulated use, and functionality following repeated use.
Any technological differences between the SPIDER™ device and the predicates have been mitigated via verification and validation testing. Thus the SPIDER™ device does not introduce any new issues of safety or effectiveness compared to other similar single port access devices currently marketed.
8. Conclusion:
The conclusion drawn from the test data is that the SPIDER™ device is as safe and effective as the predicate devices, performs similarly to other legally marketed predicate devices for laparoscopic surgery, and does not raise any new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 222009
TransEnterix, Inc. % Ms. Tammy B. Carrea Director Regulatory Affairs and Quality Assurance 3908 Patriot Drive, Suite 170 Durham, North Carolina 27703
Re: K090902
Trade/Device Name: SPIDER™ (Single Port Instrument Delivery Extended Reach) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 27, 2009 Received: June 30, 2009
Dear Carrea:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Tammy B. Carrea
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for D.O.K
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
090902
510(k) No.
If known
KO90902
Indications For Use Statement
SPIDER™ (Single Port Instrument Delivery Extended Reach) Device Name:
Indications For Use:
The SPIDER™ (Single Port Instrument Delivery Extended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery.
Prescription Use
1. Introduction
This document describes the design and implementation of a system for generating and managing unique identifiers (UIDs) at scale. UIDs are essential for identifying and tracking entities in distributed systems, databases, and various applications. The system aims to provide a reliable, efficient, and scalable solution for generating UIDs while ensuring uniqueness and minimizing collisions.
2. Requirements
The UID generation system must meet the following requirements:
- Uniqueness: The generated UIDs must be globally unique to avoid conflicts and ensure data integrity.
- Scalability: The system should be able to handle a large number of UID generation requests concurrently without performance degradation.
- Low Latency: UID generation should be fast and efficient to minimize the impact on application performance.
- Fault Tolerance: The system should be resilient to failures and continue to generate UIDs even in the presence of hardware or software issues.
- Sortability: The generated UIDs should be sortable by time to facilitate efficient querying and analysis of data.
- Customization: The system should allow customization of UID generation parameters to meet specific application requirements.
3. Design
The UID generation system is designed as a distributed service that consists of multiple UID generation nodes. Each node is responsible for generating UIDs within a specific range. The system uses a combination of techniques to ensure uniqueness, scalability, and fault tolerance.
3.1. UID Structure
The generated UIDs are 64-bit integers that consist of the following components:
- Timestamp: A 42-bit timestamp that represents the number of milliseconds since a custom epoch. This component ensures sortability and provides a rough estimate of the UID generation time.
- Worker ID: A 10-bit worker ID that identifies the UID generation node. This component ensures uniqueness across multiple nodes.
- Sequence Number: A 12-bit sequence number that is incremented for each UID generated within the same millisecond on the same node. This component ensures uniqueness within a node.
$$UID = Timestamp | WorkerID | SequenceNumber$$
3.2. UID Generation Algorithm
The UID generation algorithm is as follows:
- Get the current timestamp in milliseconds.
- If the timestamp is the same as the previous timestamp, increment the sequence number. If the sequence number reaches its maximum value (4095), wait until the next millisecond.
- If the timestamp is greater than the previous timestamp, reset the sequence number to 0.
- Combine the timestamp, worker ID, and sequence number to form the UID.
- Return the UID.
3.3. Worker ID Allocation
Each UID generation node is assigned a unique worker ID. The worker IDs are allocated by a central coordination service, such as ZooKeeper or etcd. The coordination service ensures that each node receives a unique worker ID and prevents conflicts.
3.4. Fault Tolerance
The UID generation system is designed to be fault-tolerant. If a UID generation node fails, the coordination service automatically reassigns its worker ID to another node. The system also supports replication of UID generation nodes to provide redundancy and ensure high availability.
4. Implementation
The UID generation system is implemented in Java using the Spring Framework. The system uses ZooKeeper for worker ID allocation and coordination. The system is deployed on a cluster of virtual machines using Docker and Kubernetes.
4.1. Dependencies
The following dependencies are required to build and run the UID generation system:
- Java 8 or later
- Maven 3 or later
- ZooKeeper 3.4 or later
- Spring Framework 5 or later
- Docker 18.09 or later
- Kubernetes 1.13 or later
4.2. Configuration
The UID generation system can be configured using a properties file. The following properties can be configured:
worker.id: The worker ID of the UID generation node.epoch: The custom epoch to use for the timestamp.zookeeper.connect: The ZooKeeper connection string.
4.3. API
The UID generation system provides a simple API for generating UIDs. The API consists of a single endpoint that returns a new UID.
GET /uid
json { "uid": 1234567890 }
5. Testing
The UID generation system is thoroughly tested to ensure uniqueness, scalability, and fault tolerance. The following tests are performed:
- Uniqueness Test: This test generates a large number of UIDs and verifies that they are all unique.
- Scalability Test: This test measures the throughput and latency of the system under high load.
- Fault Tolerance Test: This test simulates failures of UID generation nodes and verifies that the system continues to generate UIDs without errors.
6. Conclusion
The UID generation system provides a reliable, efficient, and scalable solution for generating UIDs. The system is designed to meet the requirements of distributed systems, databases, and various applications. The system is implemented in Java using the Spring Framework and deployed on a cluster of virtual machines using Docker and Kubernetes.
×
AND/OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSSARY)
Nike R.P. Alence for mxm
(Division Sign-Off) Division of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090902